Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
Study Details
Study Description
Brief Summary
Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Children with lower respiratory tract infection Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension |
Drug: clarithromycin (Klacid) granules for oral suspension
clarithromycin (Klacid) Granules for Oral Suspension
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Average Time From Baseline to Recovery From Fever and Other Symptoms [Baseline to 14 days]
Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection.
Secondary Outcome Measures
- Number and Type of Adverse Events [Baseline to 14 days]
Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with lower respiratory tract infection.
-
Patient is male or female > 6 months and < 12 years of age.
-
Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients
-
Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information
Exclusion Criteria:
-
Known hypersensitivity to or previously intolerant of macrolides.
-
Illness severe enough to warrant hospitalization or parenteral therapy.
-
Concomitant use of any of the following medications:
-
Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
-
Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
-
Colchicine
-
Digoxin
-
Ritonavir.
-
Severe immunodeficiency and chronic disease conditions.
-
Renal or hepatic impairment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID/Investigator# 27424 | Bangkok | Thailand | 10110 | |
| 2 | Site Reference ID/Investigator# 46824 | Bangkok | Thailand | 10120 | |
| 3 | Site Reference ID/Investigator# 16261 | Bangkok | Thailand | 10160 | |
| 4 | Site Reference ID/Investigator# 46825 | Bangkok | Thailand | 10160 | |
| 5 | Site Reference ID/Investigator# 27428 | Bangkok | Thailand | 10220 | |
| 6 | Site Reference ID/Investigator# 27425 | Bangkok | Thailand | 10260 | |
| 7 | Site Reference ID/Investigator# 27423 | Bangkok | Thailand | 10700 | |
| 8 | Site Reference ID/Investigator# 27426 | Bangkok | Thailand | 10900 | |
| 9 | Site Reference ID/Investigator# 46823 | Chiangmai | Thailand | 50180 | |
| 10 | Site Reference ID/Investigator# 27434 | Chumphon | Thailand | 86000 | |
| 11 | Site Reference ID/Investigator# 27433 | Chumphon | Thailand | 86110 | |
| 12 | Site Reference ID/Investigator# 27431 | Nakhon Ratchasima | Thailand | 30000 | |
| 13 | Site Reference ID/Investigator# 27441 | Nong khai | Thailand | 43110 | |
| 14 | Site Reference ID/Investigator# 27429 | Pisanuloke | Thailand | 65000 | |
| 15 | Site Reference ID/Investigator# 27432 | Rayong | Thailand | 21000 | |
| 16 | Site Reference ID/Investigator# 27430 | Samutsakorn | Thailand | 74000 |
Sponsors and Collaborators
- Abbott
Investigators
- Study Director: Savary Om, M.D., Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P10-813
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 337 participants were enrolled in the study. 308 were analyzed as 29 participants had protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). |
| Arm/Group Title | Klacid Granules (Total) |
|---|---|
| Arm/Group Description | Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information. |
| Period Title: Overall Study | |
| STARTED | 337 |
| COMPLETED | 328 |
| NOT COMPLETED | 9 |
Baseline Characteristics
| Arm/Group Title | Klacid Granules (Total) |
|---|---|
| Arm/Group Description | The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information. |
| Overall Participants | 308 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
4.2
|
| Age, Customized (participants) [Number] | |
| > 6 months to 3 years |
80
26%
|
| Between 3 and 5 years |
118
38.3%
|
| > 5 and < 12 years |
110
35.7%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
147
47.7%
|
| Male |
161
52.3%
|
| Region of Enrollment (participants) [Number] | |
| Thailand |
308
100%
|
| Diagnosis (participants) [Number] | |
| Bronchitis |
278
90.3%
|
| Pneumonia |
30
9.7%
|
| Risk Factor--Upper Respiratory Tract Infections (participants) [Number] | |
| URTI 1 to 2 times per year |
98
31.8%
|
| URTI 3 to 6 times per year |
76
24.7%
|
| URTI 7 to 10 times per year |
5
1.6%
|
| URTI > 10 times per year |
0
0%
|
| URTI not reported |
129
41.9%
|
| Risk Factor--Lower Respiratory Tract Infections (participants) [Number] | |
| LRTI 1 to 2 times per year |
111
36%
|
| LRTI 3 to 6 times per year |
27
8.8%
|
| LRTI 7 to 10 times per year |
9
2.9%
|
| LRTI > 10 times per year |
0
0%
|
| LRTI not reported |
161
52.3%
|
Outcome Measures
| Title | Average Time From Baseline to Recovery From Fever and Other Symptoms |
|---|---|
| Description | Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection. |
| Time Frame | Baseline to 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients. |
| Arm/Group Title | Klacid Granules (Total Number Recovered) | Klacid Granules (Bronchitis, Recovered) | Klacid Granules (Pneumonia, Recovered) |
|---|---|---|---|
| Arm/Group Description | Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information who were in the recovered population. | Participants in the recovered population who had a diagnosis of bronchitis at study entry. | Participants in the recovered population who had a diagnosis of pneumonia at study entry. |
| Measure Participants | 171 | 163 | 8 |
| Mean (Standard Deviation) [Days] |
7.18
(2.33)
|
7.14
(2.35)
|
7.88
(1.81)
|
| Title | Number and Type of Adverse Events |
|---|---|
| Description | Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details. |
| Time Frame | Baseline to 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The safety population included all participants who took at least 1 dose of Klacid. |
| Arm/Group Title | Klacid Granules (Total) |
|---|---|
| Arm/Group Description | Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information. |
| Measure Participants | 337 |
| Serious adverse events |
2
0.6%
|
| Non-serious adverse events |
1
0.3%
|
Adverse Events
| Time Frame | All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid. | |
|---|---|---|
| Adverse Event Reporting Description | The 6 serious adverse events that occurred in 2 participants and the one non-serious adverse event are summarized. | |
| Arm/Group Title | Klacid Granules (Total) | |
| Arm/Group Description | Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information. | |
All Cause Mortality |
||
| Klacid Granules (Total) | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Klacid Granules (Total) | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/337 (0.6%) | |
| General disorders | ||
| Drug ineffective | 1/337 (0.3%) | 1 |
| Infections and infestations | ||
| Pneumonia | 1/337 (0.3%) | 1 |
| Pneumonia viral | 1/337 (0.3%) | 1 |
| Metabolism and nutrition disorders | ||
| Hypophagia | 1/337 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Asthma | 1/337 (0.3%) | 1 |
| Cough | 1/337 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Klacid Granules (Total) | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/337 (0.3%) | |
| Gastrointestinal disorders | ||
| Vomiting | 1/337 (0.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | Abbott |
| Phone | 1-800-633-9110 |
- P10-813