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Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with lower respiratory tract infection | Thai children with lower respiratory tract infections on Klacid Granules for Oral Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clarithromycin (Klacid) granules for oral suspension | Drug | clarithromycin (Klacid) Granules for Oral Suspension |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Time From Baseline to Recovery From Fever and Other Symptoms | 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. | Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Type of Adverse Events | 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. | Baseline to 14 days |
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Inclusion Criteria:
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:
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment.
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Out-patients in Thailand
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| Name | Affiliation | Role |
|---|---|---|
| Savary Om, M.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27424 | Bangkok | 10110 | Thailand | |||
| Site Reference ID/Investigator# 46824 |
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Klacid Granules (Total) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bangkok |
| 10120 |
| Thailand |
| Site Reference ID/Investigator# 16261 | Bangkok | 10160 | Thailand |
| Site Reference ID/Investigator# 46825 | Bangkok | 10160 | Thailand |
| Site Reference ID/Investigator# 27428 | Bangkok | 10220 | Thailand |
| Site Reference ID/Investigator# 27425 | Bangkok | 10260 | Thailand |
| Site Reference ID/Investigator# 27423 | Bangkok | 10700 | Thailand |
| Site Reference ID/Investigator# 27426 | Bangkok | 10900 | Thailand |
| Site Reference ID/Investigator# 46823 | Chiang Mai | 50180 | Thailand |
| Site Reference ID/Investigator# 27434 | Chumphon | 86000 | Thailand |
| Site Reference ID/Investigator# 27433 | Chumphon | 86110 | Thailand |
| Site Reference ID/Investigator# 27431 | Nakhon Ratchasima | 30000 | Thailand |
| Site Reference ID/Investigator# 27441 | Nong Khai | 43110 | Thailand |
| Site Reference ID/Investigator# 27429 | Phitsanulok | 65000 | Thailand |
| Site Reference ID/Investigator# 27432 | Rayong | 21000 | Thailand |
| Site Reference ID/Investigator# 27430 | Samutsakorn | 74000 | Thailand |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Klacid Granules (Total) | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Based on per protocol population (308 participants). | Median | Full Range | years |
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| Age, Customized | Based on per protocol population (308 participants). | Number | participants |
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| Sex: Female, Male | Based on per protocol population (308 participants). | Count of Participants | Participants |
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| Region of Enrollment | Based on per protocol population (308 participants). | Number | participants |
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| Diagnosis | Participant diagnosis at study entry for the per protocol population (308 participants). | Number | participants |
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| Risk Factor--Upper Respiratory Tract Infections | The frequency in which participants had experienced upper respiratory tract infections (URTI) in the past, for the per protocol population (308 participants). | Number | participants |
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| Risk Factor--Lower Respiratory Tract Infections | The frequency in which participants had experienced lower respiratory tract infections (LRTI) in the past, for the per protocol population (308 participants). | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Time From Baseline to Recovery From Fever and Other Symptoms | 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. | 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. | Posted | Mean | Standard Deviation | Days | Baseline to 14 days |
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| Secondary | Number and Type of Adverse Events | 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. | The safety population included all participants who took at least 1 dose of Klacid. | Posted | Number | Participants | Baseline to 14 days |
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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.
The 6 serious adverse events that occurred in 2 participants and the one non-serious adverse event are summarized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Klacid Granules (Total) | 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. | 2 | 337 | 1 | 337 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drug ineffective | General disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Hypophagia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| > 5 and < 12 years |
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| URTI 7 to 10 times per year |
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| URTI > 10 times per year |
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| URTI not reported |
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| LRTI 7 to 10 times per year |
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| LRTI > 10 times per year |
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| LRTI not reported |
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