Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT03248297
Collaborator
Merck Sharp & Dohme LLC (Industry)
756
1
3
32.6
23.2

Study Details

Study Description

Brief Summary

This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥ 18 hours to identical oral regimens of 1 gram of azithromycin, 1 gram of azithromycin+2 grams of amoxicillin or placebo. Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This 3-arm study is a large randomized clinical trial designed to evaluate the comparative effectiveness and safety of single dose oral azithromycin or combined azithromycin+amoxicillin compared to placebo for the prevention of peripartum infections and sepsis in laboring women. We have previously shown the effectiveness of azithromycin for extended spectrum antibiotic prophylaxis in addition to the standard cephalosporin alone for reduction of post-cesarean infections. In LICs, the fraction of maternal infection and sepsis from cesarean delivery is minimal. Therefore, it is necessary to evaluate strategies aimed at reducing these morbidities in women who have vaginal births. There is an increased risk of infection in women who have prolonged labor or prolonged rupture of membranes. Drawing from our findings with azithromycin-based extended antibiotic prophylaxis for cesarean delivery, we propose to adapt the intervention and evaluate a single oral dose of azithromycin (with or without oral amoxicillin) to prevent maternal peripartum infection and sepsis. This study, performed over a course of 3 years in 5 collaborating hospitals in Cameroon, Africa, will randomize 750 women in labor with prolonged rupture of membranes ≥ 8 hours or prolonged labor ≥18 hours to 1 gram of oral azithromycin, 1 gram of azithromycin+2 grams of amoxicillin, compared to usual care (placebo). Women will be followed to ascertain maternal infectious outcomes and perinatal outcomes.

Study Design

Study Type:
Interventional
Actual Enrollment :
756 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Azithromycin With or Without Amoxicillin to Prevent Peripartum Infection and Sepsis in Laboring High-risk Women: 3-Arm RCT
Actual Study Start Date :
Jan 12, 2018
Actual Primary Completion Date :
May 15, 2020
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azithromycin and amoxicillin placebo

Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo.

Drug: Azithromycin
Azithromycin tablet

Drug: Placebo
Placebo tablet

Experimental: Azithromycin + amoxicillin

Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose.

Drug: Azithromycin and amoxicillin
azithromycin and amoxicillin
Other Names:
  • azithromycin, amoxicillin
  • Placebo Comparator: Usual Care

    This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin)

    Drug: Placebo
    Placebo tablet

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Who Experienced Composite Peripartum Infection or Death [Up to 6 weeks after delivery]

      Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death

    Secondary Outcome Measures

    1. Number of Participants Who Experienced Pyelonephritis [Up to hospital discharge]

      Other Infections

    2. Number of Participants Who Experienced Breast Infection [Up to 6 weeks after delivery]

      Other infections

    3. Number of Participants Who Experienced Other Infection [up to 6 weeks after delivery]

      Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria

    4. Number of Participants Who Experienced Fever [up to 6 weeks after delivery]

      Any fever higher than 38C

    5. Number of Participants Who Experienced Hypothermia [up to 6 weeks after delivery]

      Any hypothermia less than 36C

    6. Number of Participants Who Needed PP Antibiotic [up to 6 weeks after delivery]

      Any postpartum antibiotic

    7. Number of Participants Who Experienced Transfusion [up to 6 weeks after delivery]

      Blood transfusion

    8. Number of Participants Who Experienced Stillbirth [delivery]

      Any stillbirth

    9. Length of Stay [up to 6 weeks postpartum]

      Length of stay in days

    10. Number of Participants Who Experienced a Clinic Visit [up to 6 weeks after delivery]

      Clinic visit after discharge

    11. Number of Participants Who Experienced a Maternal Readmission [up to 6 weeks after delivery]

      Maternal readmission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women ≥ 37 weeks' viable singleton or twin gestation in labor planning a vaginal delivery with
    1. Prolonged membrane rupture (≥8 hours) or

    2. Prolonged labor (≥18 hours).

    Exclusion Criteria:
    • Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization: because standard antibiotic therapy for these conditions may confound trial intervention.

    • Allergy to azithromycin or amoxicillin

    • Plan for cesarean delivery prior to enrollment

    • Fetal demise or major congenital anomaly: Major congenital anomalies may confound assessment of neonatal outcomes and every attempt will be made up front to exclude them from randomization. However, some unrecognized fetal anomalies may inevitably be randomized. These will not be excluded post-randomization from the primary (maternal outcome) analysis; they will be taken into consideration in the secondary analyses of neonatal outcomes.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cameroon Baptist Convention Health Services Bamenda Cameroon

    Sponsors and Collaborators

    • University of Alabama at Birmingham
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Alan Tita, MD, PhD, University of Alabama at Birmingham

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Alan Tita, Professor and Director, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT03248297
    Other Study ID Numbers:
    • CHI UAB MISP # 54628
    First Posted:
    Aug 14, 2017
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Period Title: Overall Study
    STARTED 253 253 250
    COMPLETED 253 253 250
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care Total
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet Total of all reporting groups
    Overall Participants 253 253 250 756
    Age, Customized (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    27.2
    (5.3)
    26.4
    (5.6)
    26.0
    (5.3)
    26.5
    (5.4)
    Sex: Female, Male (Count of Participants)
    Female
    253
    100%
    253
    100%
    250
    100%
    756
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    253
    100%
    253
    100%
    250
    100%
    756
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    253
    100%
    253
    100%
    250
    100%
    756
    100%
    White
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Gestational age at Randomization (Weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Weeks]
    39.4
    (1.5)
    39.2
    (1.4)
    39.2
    (1.4)
    39.3
    (1.4)

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Who Experienced Composite Peripartum Infection or Death
    Description Maternal peripartum infection including chorioamnionitis, endometritis, wound infection/abscess, sepsis, and death
    Time Frame Up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    15
    5.9%
    17
    6.7%
    24
    9.6%
    2. Secondary Outcome
    Title Number of Participants Who Experienced Pyelonephritis
    Description Other Infections
    Time Frame Up to hospital discharge

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    2
    0.8%
    2
    0.8%
    3
    1.2%
    3. Secondary Outcome
    Title Number of Participants Who Experienced Breast Infection
    Description Other infections
    Time Frame Up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    2
    0.8%
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Number of Participants Who Experienced Other Infection
    Description Includes Hepatitis B, thyroid infection, vaginal infection, viral infection, leg cellulitis, unknown abdominal infection,malaria
    Time Frame up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    4
    1.6%
    3
    1.2%
    1
    0.4%
    5. Secondary Outcome
    Title Number of Participants Who Experienced Fever
    Description Any fever higher than 38C
    Time Frame up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    22
    8.7%
    21
    8.3%
    28
    11.2%
    6. Secondary Outcome
    Title Number of Participants Who Experienced Hypothermia
    Description Any hypothermia less than 36C
    Time Frame up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    9
    3.6%
    11
    4.3%
    15
    6%
    7. Secondary Outcome
    Title Number of Participants Who Needed PP Antibiotic
    Description Any postpartum antibiotic
    Time Frame up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    18
    7.1%
    18
    7.1%
    26
    10.4%
    8. Secondary Outcome
    Title Number of Participants Who Experienced Transfusion
    Description Blood transfusion
    Time Frame up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    8
    3.2%
    3
    1.2%
    4
    1.6%
    9. Secondary Outcome
    Title Number of Participants Who Experienced Stillbirth
    Description Any stillbirth
    Time Frame delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    1
    0.4%
    0
    0%
    1
    0.4%
    10. Secondary Outcome
    Title Length of Stay
    Description Length of stay in days
    Time Frame up to 6 weeks postpartum

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Mean (Standard Deviation) [days]
    3.7
    (2.0)
    3.7
    (2.2)
    3.8
    (3.1)
    11. Secondary Outcome
    Title Number of Participants Who Experienced a Clinic Visit
    Description Clinic visit after discharge
    Time Frame up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    13
    5.1%
    7
    2.8%
    10
    4%
    12. Secondary Outcome
    Title Number of Participants Who Experienced a Maternal Readmission
    Description Maternal readmission
    Time Frame up to 6 weeks after delivery

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    Measure Participants 253 253 250
    Count of Participants [Participants]
    11
    4.3%
    4
    1.6%
    5
    2%

    Adverse Events

    Time Frame up to 6 weeks after delivery
    Adverse Event Reporting Description
    Arm/Group Title Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Arm/Group Description Patients in this arm will receive 1 gram oral azithromycin as a single dose and amoxicillin placebo. Azithromycin: Azithromycin tablet Placebo: Placebo tablet Patients in this arm will receive 1 gram oral azithromycin and 2 grams oral amoxicillin in a single dose. Azithromycin and amoxicillin: azithromycin and amoxicillin This arm will consist of routine care at the clinical sites (which is usually no antibiotic). They will receive placebo (for azithromycin) and placebo (for amoxicillin) Placebo: Placebo tablet
    All Cause Mortality
    Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/253 (0%) 0/253 (0%) 0/250 (0%)
    Serious Adverse Events
    Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/253 (0%) 0/253 (0%) 0/250 (0%)
    Other (Not Including Serious) Adverse Events
    Azithromycin and Amoxicillin Placebo Azithromycin + Amoxicillin Usual Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/253 (0%) 0/253 (0%) 0/250 (0%)

    Limitations/Caveats

    [Not Specified]

    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 Alan Tita, MD
    Organization University of Alabama at Birmingham
    Phone 205-934-5612
    Email atita@uab.edu
    Responsible Party:
    Alan Tita, Professor and Director, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT03248297
    Other Study ID Numbers:
    • CHI UAB MISP # 54628
    First Posted:
    Aug 14, 2017
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Mar 1, 2022