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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00851487
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : February 26, 2009
Sponsor:
Collaborator:
World Health Organization
Information provided by:
Pakistan Institute of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Infections Pneumonia Drug: Amoxicillin Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Amoxicillin
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
Other Name: Amoxycillin

Placebo Comparator: Placebo
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




Primary Outcome Measures :
  1. The primary outcome measure was treatment failure within the first 72 hours of therapy [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. The secondary outcome measure was treatment failure on the third follow-up (day 5) plus non-improvement [ Time Frame: 5 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851487


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

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Responsible Party: Dr. Tabish Hazir, ARI Research Cell, Children Hospital, PIMS, Islamabad
ClinicalTrials.gov Identifier: NCT00851487    
Other Study ID Numbers: NARIMA Study Group
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: February 26, 2009
Last Verified: February 2009
Keywords provided by Pakistan Institute of Medical Sciences:
ARI
LRTI
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Infection
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents