PRET: Partnership for Rapid Elimination of Trachoma
Study Details
Study Description
Brief Summary
Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes the use of antibiotic treatment to reduce the community pool of infection with C. trachomatis. The objective of this study is to conduct a randomized, community-based trial in three countries (Niger, Tanzania and The Gambia), representing different baseline endemicities, of alternative coverages and frequencies of administration of mass antibiotic treatment as well as to determine the cost-effectiveness of these different strategies from a program perspective.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
A randomized, 2x2 factorial designed trial will be implemented in each of the three countries. Communities will be randomized to two different coverage targets (80%-89% versus ≥90%) for three years of mass treatment.
In The Gambia and Tanzania, communities will be further randomized to yearly mass treatment versus mass treatment at baseline followed by yearly mass treatment only if trachoma prevalence in sentinel children is greater than 5%. The communities will continue to be followed and treatment will resume if trachoma prevalence is found to be 20% or greater at the 12 or 18 month surveys.
In Niger, communities will be randomized to the different coverage levels for annual mass azithromycin distribution and further randomized to biannual treatment at the two coverage targets for children ages twelve or younger.
Cross-sectional rates of trachoma and infection will be determined by examining sentinel children, age five years or younger, randomly selected from each community based on a community census. The census will be updated each year, and villages will be monitored at baseline, 6, 12, 18, 24, 30, and 36 months for infection and clinical disease.
The three-year study is in accord with the WHO guidelines which recommend three years of annual mass treatment followed by a re-survey to determine need for further treatment. The investigators will evaluate the efficacy of guiding further mass treatment according to a laboratory test for Chlamydia or WHO guidelines. Where investigators estimate communities have infection rates less than 5% in sentinel children, or trachomatous inflammation (TF) ( rates less than 5%, the community will be "graduated" from further mass treatment and followed for up to three years to look for evidence of re-emergent infection and disease. If rates of infection are found to be 20% or more return at the 12 or 18 month survey, mass treatment will be re-initiated.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ≥90% coverage with azithromycin target Selected communities will receive mass treatment annually for three years. |
Drug: Azithromycin
Comparison of community coverage rate
Other Names:
|
| Active Comparator: 80%-89% coverage with azithromycin target Selected communities will receive mass treatment annually for three years. |
Drug: Azithromycin
Comparison of community coverage rate
Other Names:
|
| Active Comparator: ≥90% coverage with azithromycin , treatment based Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. |
Drug: Azithromycin
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Names:
|
| Active Comparator: 80%-89% coverage with azithromycin : treatment based Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. |
Drug: Azithromycin
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline [At baseline]
Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years. The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.
- Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months [3 years]
100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia. 50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection. Outcomes are reported at the community level because raw data could not be accessed. There is no way to determine how many participants were examined in each arm.
Eligibility Criteria
Criteria
Inclusion criteria for communities:
-
Communities are located in the target districts and accessible by vehicle
-
The community leaders consent to have the community enrolled
-
Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
-
The community size is <5,000 persons or >250 persons.
If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:
-
The child is age 5 years or younger
-
The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).
-
The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
-
The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)
-
The child must have an identifiable guardian capable of providing consent to participate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Proctor Foundation | San Francisco | California | United States | 94143 |
| 2 | Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
| 3 | London School of Hygiene and Tropical Medicine | London | United Kingdom | WC1E 7HT |
Sponsors and Collaborators
- Johns Hopkins University
- Bill and Melinda Gates Foundation
Investigators
- Principal Investigator: Sheila West, PhD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NA_00018439
Study Results
Participant Flow
| Recruitment Details | The study recruited communities with trachoma rates 20 % or higher from 3 countries - Tanzania, Gambia and Niger. Protocol Enrollment refers to the number of communities, not the number of participants enrolled. The final analysis was done at community level. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based |
|---|---|---|---|---|
| Arm/Group Description | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. |
| Period Title: At Baseline | ||||
| STARTED | NA | NA | NA | NA |
| Niger | NA | NA | NA | NA |
| Gambia | NA | NA | NA | NA |
| Tanzania | NA | NA | NA | NA |
| COMPLETED | NA | NA | NA | NA |
| NOT COMPLETED | NA | NA | NA | NA |
| Period Title: At Baseline | ||||
| STARTED | NA | NA | NA | NA |
| Niger | NA | NA | NA | NA |
| Gambia | NA | NA | NA | NA |
| Tanzania | NA | NA | NA | NA |
| COMPLETED | NA | NA | NA | NA |
| NOT COMPLETED | NA | NA | NA | NA |
Baseline Characteristics
| Arm/Group Title | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. | Total of all reporting groups |
| Overall Participants | NA | NA | NA | NA | 0 |
| Overall community | 40 | 40 | 24 | 24 | 128 |
| Age, Customized (community) [Count of Units] | |||||
| Age not analyzed |
NA
|
NA
|
NA
|
NA
|
NA
|
| Sex/Gender, Customized (community) [Count of Units] | |||||
| Sex/Gender not analyzed |
NA
|
NA
|
NA
|
NA
|
NA
|
| Region of Enrollment (community) [Number] | |||||
| Tanzania |
16
|
16
|
0
|
0
|
32
|
| Gambia |
12
|
12
|
12
|
12
|
48
|
| Niger |
12
|
12
|
12
|
12
|
48
|
Outcome Measures
| Title | Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline |
|---|---|
| Description | Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years. The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination. |
| Time Frame | At baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| At baseline 8 communities were randomized to each arm in Tanzania, 12 communities were randomized to each arm in Gambia and Niger. Stop rule could not be applied in Tanzania.Communities in stop arm were moved to ≥90% coverage or 80%-89% coverage with azithromycin target arm and only main effect of coverage was analyzed in Tanzania. |
| Arm/Group Title | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coveage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based |
|---|---|---|---|---|
| Arm/Group Description | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. |
| Measure Participants | NA | NA | NA | NA |
| Measure community | 40 | 40 | 24 | 24 |
| Prevalence of trachoma in Tanzania at baseline |
30.7
(16.3)
|
30.3
(13.5)
|
31.1
(9.5)
|
30.5
(10.4)
|
| C.trachomatis infection in Tanzania at baseline |
24.6
(12.4)
|
17.8
(10.3)
|
23.0
(11.2)
|
22.4
(23.3)
|
| prevalence of trachoma in Gambia at baseline |
7.4
(26.1)
|
5.6
(23.1)
|
6.2
(24.1)
|
6.1
(23.8)
|
| C.trachomatis infection in Gambia at baseline |
0.9
(9.9)
|
0.7
(8.6)
|
1.2
(10.8)
|
0.2
(2.9)
|
| prevalence of trachoma in Niger at baseline |
28.4
(13.9)
|
27.0
(17.3)
|
23.9
(12.0)
|
24.7
(13.0)
|
| C.trachomatis infection in Niger at baseline |
21.9
(16.7)
|
20.5
(16.8)
|
15.6
(8.8)
|
24.9
(14.1)
|
| Title | Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months |
|---|---|
| Description | 100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia. 50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection. Outcomes are reported at the community level because raw data could not be accessed. There is no way to determine how many participants were examined in each arm. |
| Time Frame | 3 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| We analyzed and reported the results of the trial at community level. |
| Arm/Group Title | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coveage With Azithromycin, Treatment Based | 80%-89% Coverage With Azithromycin: Treatment Based |
|---|---|---|---|---|
| Arm/Group Description | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. |
| Measure Participants | NA | NA | NA | NA |
| Measure community | 40 | 40 | 24 | 24 |
| Prevalence of trachoma (TF) in Tanzania at 3 years |
9.0
(5.9)
|
6.1
(4.0)
|
||
| C.trachomatis infection in Tanzania at 3 years |
5.4
(3.7)
|
4.0
(2.7)
|
||
| Prevalence of trachoma (TF) in Gambia at 3 years |
3.0
(17.1)
|
2.3
(14.9)
|
3.2
(17.6)
|
2.5
(15.7)
|
| C.trachomatis infection in Gambia at 3 years |
0.2
(4.1)
|
1.0
(9.5)
|
0.7
(8.2)
|
0.2
(4.2)
|
| Prevalence of trachoma (TF) in Niger at 3 years |
8.9
(8.8)
|
7.1
(7.8)
|
5.4
(3.9)
|
10.1
(10.5)
|
| C.trachomatis infection in Niger at 3 years |
7.1
(6.8)
|
4.6
(7.9)
|
3.3
(3.6)
|
4.4
(6.0)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ≥90% Coverage With Azithromycin Target, 80%-89% Coverage With Azithromycin Target |
|---|---|---|
| Comments | This is analysis done in Tanzania: Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection. | |
| Type of Statistical Test | Superiority | |
| Comments | Predicted prevalence was estimated in each community using the baseline observed prevalence, treatment arm & parameters estimated from square root transformed model.For each arm estimated prevalences were averaged.Difference in adjusted mean prevalence for enhanced arm and standard arm was calculated.For confidence intervals for adjusted difference,steps 1 to 4 for 1000 bootstrap samples were repeated.Median of adjusted mean differences, corresponding 2.5 % & 97.5 % percentiles were reported. | |
| Statistical Test of Hypothesis | p-Value | 0.22 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 1.4 | |
| Confidence Interval |
(2-Sided) 95% -1 to 3.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 80%-89% Coverage With Azithromycin Target |
|---|---|---|
| Comments | This is the analysis done in Tanzania: Only the main effect of coverage was analyzed.We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage. Here we are looking at the prevalence of trachoma | |
| Type of Statistical Test | Superiority | |
| Comments | For each community using the baseline observed prevalence, treatment arm and parameters estimated from square root transformed model we estimated predicted prevalence.For each arm we average estimated prevalences.The difference in the adjusted mean prevalence for enhanced arm and standard arm was then calculated.In order to derive the confidence intervals for the adjusted difference, we repeated Steps 1 to 4 for 1000 bootstrap samples.The median of the adjusted mean differences were reported. | |
| Statistical Test of Hypothesis | p-Value | 0.73 |
| Comments | ||
| Method | Ordinary least squares linear regression | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.6 | |
| Confidence Interval |
(2-Sided) 95% -0.3 to 5.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | ≥90% Coverage With Azithromycin Target, 80%-89% Coverage With Azithromycin Target, ≥90% Coveage With Azithromycin , Treatment Based, 80%-89% Coverage With Azithromycin : Treatment Based |
|---|---|---|
| Comments | This is the statistical analysis for Niger: We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of infection. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.20 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Median Difference (Final Values) |
| Estimated Value | -4.6 | |
| Confidence Interval |
(2-Sided) 95% -11.1 to 1.9 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | ≥90% Coverage With Azithromycin Target, 80%-89% Coverage With Azithromycin Target, ≥90% Coveage With Azithromycin , Treatment Based, 80%-89% Coverage With Azithromycin : Treatment Based |
|---|---|---|
| Comments | This is the statistical analysis for Niger: We hypothesized that increasing the coverage of MDA to greater than 90 % as monitored in children would result in more rapid decline in infection and trachoma compared to usual coverage.Here we are looking at the prevalence of trachoma. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | Regression, Linear | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 2.4 | |
| Confidence Interval |
(2-Sided) 95% -7.7 to 12.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 3 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Mass drug administration was done for all the communities in each branch. Adverse events were planned to be collected per community per arm. No adverse event was reported in any community in all three countries. | |||||||
| Arm/Group Title | ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | ||||
| Arm/Group Description | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Selected communities will receive mass treatment annually for three years. Azithromycin: Comparison of community coverage rate | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. | Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Niger, treatment will be every 6-months for children ages twelve and under. Azithromycin: Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months. | ||||
All Cause Mortality |
||||||||
| ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| ≥90% Coverage With Azithromycin Target | 80%-89% Coverage With Azithromycin Target | ≥90% Coverage With Azithromycin , Treatment Based | 80%-89% Coverage With Azithromycin : Treatment Based | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Sheila K West |
|---|---|
| Organization | Johns Hopkins University |
| Phone | 410 955 2606 |
| shwest@jhmi.edu |
- NA_00018439