Trial Outcomes & Findings for Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension. (NCT NCT01076166)

Last Updated: 2011-04-11

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

337 participants

Primary outcome timeframe

Baseline to 14 days

Results posted on

2011-04-11

Participant Flow

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).

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	337
Overall Study COMPLETED	328
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	3
Overall Study Symptoms improved/resolved	6

Baseline Characteristics

Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Klacid Granules (Total) n=308 Participants 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.
Age Continuous	4.2 years n=5 Participants
Age, Customized > 6 months to 3 years	80 participants n=5 Participants
Age, Customized Between 3 and 5 years	118 participants n=5 Participants
Age, Customized > 5 and < 12 years	110 participants n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants
Sex: Female, Male Male	161 Participants n=5 Participants
Region of Enrollment Thailand	308 participants n=5 Participants
Diagnosis Bronchitis	278 participants n=5 Participants
Diagnosis Pneumonia	30 participants n=5 Participants
Risk Factor--Upper Respiratory Tract Infections URTI 1 to 2 times per year	98 participants n=5 Participants
Risk Factor--Upper Respiratory Tract Infections URTI 3 to 6 times per year	76 participants n=5 Participants
Risk Factor--Upper Respiratory Tract Infections URTI 7 to 10 times per year	5 participants n=5 Participants
Risk Factor--Upper Respiratory Tract Infections URTI > 10 times per year	0 participants n=5 Participants
Risk Factor--Upper Respiratory Tract Infections URTI not reported	129 participants n=5 Participants
Risk Factor--Lower Respiratory Tract Infections LRTI 1 to 2 times per year	111 participants n=5 Participants
Risk Factor--Lower Respiratory Tract Infections LRTI 3 to 6 times per year	27 participants n=5 Participants
Risk Factor--Lower Respiratory Tract Infections LRTI 7 to 10 times per year	9 participants n=5 Participants
Risk Factor--Lower Respiratory Tract Infections LRTI > 10 times per year	0 participants n=5 Participants
Risk Factor--Lower Respiratory Tract Infections LRTI not reported	161 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 14 days

Population: 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.

Outcome measures

Outcome measures
Measure	Klacid Granules (Total Number Recovered) n=171 Participants 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.	Klacid Granules (Bronchitis, Recovered) n=163 Participants Participants in the recovered population who had a diagnosis of bronchitis at study entry.	Klacid Granules (Pneumonia, Recovered) n=8 Participants Participants in the recovered population who had a diagnosis of pneumonia at study entry.
Average Time From Baseline to Recovery From Fever and Other Symptoms	7.18 Days Standard Deviation 2.33	7.14 Days Standard Deviation 2.35	7.88 Days Standard Deviation 1.81

SECONDARY outcome

Timeframe: Baseline to 14 days

Population: The safety population included all participants who took at least 1 dose of Klacid.

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.

Outcome measures

Outcome measures
Measure	Klacid Granules (Total Number Recovered) n=337 Participants 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.	Klacid Granules (Bronchitis, Recovered) Participants in the recovered population who had a diagnosis of bronchitis at study entry.	Klacid Granules (Pneumonia, Recovered) Participants in the recovered population who had a diagnosis of pneumonia at study entry.
Number and Type of Adverse Events Serious adverse events	2 Participants	—	—
Number and Type of Adverse Events Non-serious adverse events	1 Participants	—	—

Adverse Events

Klacid Granules (Total)

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Klacid Granules (Total) n=337 participants at risk 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.
General disorders Drug ineffective	0.30% 1/337 • Number of events 1 • 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.
Infections and infestations Pneumonia	0.30% 1/337 • Number of events 1 • 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.
Infections and infestations Pneumonia viral	0.30% 1/337 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Asthma	0.30% 1/337 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Cough	0.30% 1/337 • Number of events 1 • 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.
Metabolism and nutrition disorders Hypophagia	0.30% 1/337 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Klacid Granules (Total) n=337 participants at risk 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.
Gastrointestinal disorders Vomiting	0.30% 1/337 • Number of events 1 • 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.

Additional Information

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