Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months

NCT00851487 | Completed DMC

• 1 other identifier: NARIMA Study Group
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Many children with "non-severe pneumonia" (cough and fast breathing) have neither clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of antibiotics for these cases is leading to resistant strains of bacteria in the community. Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of antibiotic prescription for ARI are not necessary since most of these infections are viral and do not respond to antibiotic therapy which will be source of resistance in the community. To address this issue the investigators conducted this randomized, double blind placebo controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe pneumonia taking into account all the necessary safety precautions for their well being. The study hypothesis was that the clinical outcome of children 2 to 59 months of age with cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is equivalent, whether they are treated with amoxicillin or placebo.

Conditions

Acute Respiratory Infections; Pneumonia

Keywords

ARI; LRTI

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure was treatment failure within the first 72 hours of therapy

  3 days

Secondary Outcomes (1)

• The secondary outcome measure was treatment failure on the third follow-up (day 5) plus non-improvement

  5 days

Study Arms (2)

Amoxicillin

EXPERIMENTAL

Oral amoxicillin in the dose of 15 mg/kg/dose 8 hourly was given as an active drug

Drug: Amoxicillin

Placebo

PLACEBO COMPARATOR

The placebo was similar in colour, consistency and volume as oral amoxicillin

Drug: Placebo

Interventions

Amoxicillin DRUG

Oral Amoxicillin 15 mg/kg/dose 8 hourly

Also known as: Amoxycillin

Amoxicillin

Placebo DRUG

The placebo was similar in colour, consistency and volume as oral amoxicillin

Placebo

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2 to 59 months attending the outpatient's clinics of participating sites
• WHO defined non-severe pneumonia
• Accessibility for follow-up
• Written informed consent by a parent or legal guardian

You may not qualify if:

• WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following:
• Cyanosis
• Inability to drink
• Convulsions
• Abnormally sleepy or difficult to wake
• Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart).
• All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma.
• Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly.
• Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc.
• Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc.
• Children who have taken the appropriate doses of WHO-recommended dose of anti microbial drug for 48 hours prior to presentation.
• A history of hospitalization in the past 2 weeks
• Measles or a history of measles within the last month: Measles recognized by presence of fever with rash, and conjunctivitis.
• Prior enrolment in the current trial.
• Known penicillin allergy, including a history of rash, urticaria, or anaphylactic symptoms.

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead
• World Health Organization: collaborator

Study Sites (1)

ARI Research Cell, Children Hospital, PIMS

Islamabad, Federal Capital, 44000, Pakistan

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dr. Tabish Hazir, FCPS-Peds

  Overall Head of Research Cell

  PRINCIPAL INVESTIGATOR

• Dr. Yusra Ashraf, MBBS

  Research Administrator to ARI Research Cell

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 25, 2009
• First Posted: February 26, 2009
• Study Start: January 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: February 26, 2009

Record last verified: 2009-02

Locations

PA (1)