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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

Pakistan Institute of
Sponsor:
Medical Sciences

World Health
Collaborator:
Organization

Information Pakistan Institute of


provided by: Medical Sciences

ClinicalTrials.g
NCT00851487
ov Identifier:

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 Drug: Amoxicillin
Pneumonia Drug: Placebo

Study Type: Interventional

Study Design: Allocation: Randomized


Control: Placebo Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Pneumonia


Drug Information available for: Amoxicillin Amoxicillin sodium
Amoxicillin trihydrate
U.S. FDA Resources

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 Drug: Amoxicillin
Oral amoxicillin in the dose of 15 Oral Amoxicillin 15 mg/kg/dose 8 hourly
mg/kg/dose 8 hourly was given as an Other Names:
active drug • Amoxicillin
Intervention: Drug: Amoxicillin
• Amoxycillin

Placebo: Placebo Comparator Drug: Placebo


The placebo was similar in colour, The placebo was similar in colour,
consistency and volume as oral consistency and volume as oral amoxicillin
amoxicillin
Intervention: Drug: Placebo

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

More Information

Additional Information:
The URL has the background, contacts, personnel, publications, project status of ARI
Research Cell

No publications provided

Responsible Party: ARI Research Cell, Children Hospital, PIMS,


Islamabad ( Dr. Tabish Hazir )
ClinicalTrials.gov Identifier: NCT00851487 History of Changes
Other Study ID Numbers: NARIMA Study Group
Study First Received: February 25, 2009
Last Updated: February 25, 2009
Health Authority: Pakistan: Ministry of Health

Keywords provided by Pakistan Institute of Medical Sciences:


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

ClinicalTrials.gov processed this record on January 23, 2011

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