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Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months
This study has been completed.
First Received: February 25, 2009   No Changes Posted
Sponsors and Collaborators: Pakistan Institute of Medical Sciences
World Health Organization
Information provided by: Pakistan Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT00851487
  Purpose

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.


Condition Intervention
Acute Respiratory Infections
Pneumonia
Drug: Amoxicillin
Drug: Placebo

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Multicentre Double Blind Trial of Amoxicillin Compared With Placebo for Treatment of WHO Defined Non-Severe Pneumonia in Children Aged 2-59 Months: NARIMA Study Group

Resource links provided by NLM:


Further study details as provided by Pakistan Institute of Medical Sciences:

Primary Outcome Measures:
  • The primary outcome measure was treatment failure within the first 72 hours of therapy [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary outcome measure was treatment failure on the third follow-up (day 5) plus non-improvement [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 900
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Amoxicillin: Experimental
Oral amoxicillin in the dose of 15 mg/kg/dose 8 hourly was given as an active drug
Drug: Amoxicillin
Oral Amoxicillin 15 mg/kg/dose 8 hourly
Placebo: Placebo Comparator
The placebo was similar in colour, consistency and volume as oral amoxicillin
Drug: Placebo
The placebo was similar in colour, consistency and volume as oral amoxicillin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. Cyanosis
    2. Inability to drink
    3. Convulsions
    4. 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.
  • The children living outside the municipal limits of the city who cannot be followed up.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00851487

Locations
Pakistan, Federal Capital
ARI Research Cell, Children Hospital, PIMS
Islamabad, Federal Capital, Pakistan, 44000
Sponsors and Collaborators
Pakistan Institute of Medical Sciences
World Health Organization
Investigators
Principal Investigator: Dr. Tabish Hazir, FCPS-Peds Overall Head of Research Cell
Study Director: Dr. Yusra Ashraf, MBBS Research Administrator to ARI Research Cell
  More Information

Additional Information:
No publications provided

Responsible Party: ARI Research Cell, Children Hospital, PIMS, Islamabad ( Dr. Tabish Hazir )
Study ID Numbers: NARIMA Study Group
Study First Received: February 25, 2009
Last Updated: February 25, 2009
ClinicalTrials.gov Identifier: NCT00851487     History of Changes
Health Authority: Pakistan: Ministry of Health

Keywords provided by Pakistan Institute of Medical Sciences:
ARI
LRTI

Study placed in the following topic categories:
Anti-Infective Agents
Anti-Bacterial Agents
Amoxicillin
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Pneumonia

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Amoxicillin
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Lung Diseases
Infection
Pharmacologic Actions
Pneumonia

ClinicalTrials.gov processed this record on September 10, 2009