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

July 19, 2011 updated by: Federal University of Bahia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

820

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 40160-170
        • Professor Hosannah de Oliveira Pediatric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amoxicillin given twice a day
Drug: Amoxicillin
amoxicillin 50mg/kg/day given in two different administration schemes
Other Names:
  • Placebo with amoxicillin,in the opposite posologic scheme
Active Comparator: Amoxicillin given three times a day
Drug: Amoxicillin
amoxicillin 50mg/kg/day given in two different administration schemes
Other Names:
  • Placebo with amoxicillin,in the opposite posologic scheme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical efficacy
Time Frame: 48 hours
resolution of fever, difficulty breathing and tachypnea
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of cough
Time Frame: 96 hours
Disappearance of cough
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Bahia

Investigators

  • Principal Investigator: Cristiana M Nascimento-Carvalho, MD, PhD, Federal University of Bahia School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (Estimate)

September 14, 2010

Study Record Updates

Last Update Posted (Estimate)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APR0127/2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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