Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

820 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired pneumonia.

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Detailed Description

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Conditions

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Community-acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amoxicillin given twice a day

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

amoxicillin 50mg/kg/day given in two different administration schemes

Amoxicillin given three times a day

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

amoxicillin 50mg/kg/day given in two different administration schemes

Interventions

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Amoxicillin

amoxicillin 50mg/kg/day given in two different administration schemes

Intervention Type DRUG

Other Intervention Names

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Placebo with amoxicillin,in the opposite posologic scheme

Eligibility Criteria

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Inclusion Criteria

* Children aged between 2 and 59 months
* Report of respiratory complaints
* Presence of pulmonary infiltrate on chest x-ray taken on admission and read by the pediatrician on duty

Exclusion Criteria

* lower chest indrawing
* danger signs (inability to drink, convulsions, somnolence, central cyanosis, grunting in a calm child)
* diagnosed underlying chronic diseases (anatomic abnormalities of the respiratory tract, chronic pulmonary illness besides asthma, immunological defects, progressing neurological disorders, psychomotor retardation, heart disease with clinical repercussion, hemoglobinopathy, liver or kidney disease)
* severe malnutrition
* other concurrent infection
* hospitalization during the previous 7 days
* amoxicillin or similar antibiotic use during the last 48 hours
* allergy to amoxicillin
* history of aspiration

Minimum Eligible Age

2 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No