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Efficacy Study for Standard Versus Double Dose of Amoxicillin in WHO Defined Non-severe Pneumonia

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. Identifier: NCT01375426
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : June 17, 2011
World Health Organization
Information provided by:
ARI Research Cell

Brief Summary:

Over a period of years there have been numerous reports from many developing countries including Pakistan showing a rising treatment failure rate with first line drugs (amoxicillin and cotrimoxazole) in non-severe pneumonia in children. The reasons for this rise in treatment failure rates are not entirely clear but one of the reasons is thought to be increasing antimicrobial resistance of H. influenzae and Strep. pneumoniae to first line drugs. There is microbiological data which suggests that this resistance can be overcome by increasing the dose of amoxicillin. The investigators propose to treat non-severe pneumonia with double dose amoxicillin in an attempt to demonstrate a decrease in treatment failure rates. This will be a multicentre, double blind randomized controlled trial in children 2-59 months of age with non-severe pneumonia comparing the clinical outcome between the standard and double dose groups.

It has been felt that the WHO criteria for treatment failure in children with pneumonia are too stringent and have never been systematically evaluated in the community. The investigators also propose to modify WHO criteria and field test them in this trial in an attempt to demonstrate that less stringent treatment failure criteria would have an impact on the overall treatment failure rates in pneumonia.


Therapy outcome with double dose of oral amoxicillin is not different than the standard dose of amoxicillin, when used for three days for the treatment of non-severe pneumonia in 2-59 months old children.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: Oral amoxicillin Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Standard Versus Double Dose of Amoxicillin in the Treatment of Non-Severe Pneumonia in Children Aged 2-59 Months: A Multi-centre Randomized Double Blind Controlled Trial in Pakistan
Study Start Date : September 2003
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Primary Outcome Measures :
  1. Number of children with non-severe pneumonia failing treatment with standard and double dose amoxicillin

Secondary Outcome Measures :
  1. To measure the difference in treatment failure rates by day 5 by using the treatment failure definitions by WHO and the modified study definitions.

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

Inclusion Criteria:

  1. They are aged 2-59 months.
  2. Diagnosed with WHO defined non-severe pneumonia (Table 1).

Exclusion Criteria:

  • Children with signs of WHO defined severe or very severe disease.
  • Known penicillin allergy, with a history of accelerated rash, urticaria, or anaphylactic symptoms. Complicating acute non-pulmonary or chronic illness .
  • The children living outside the municipal limits of the city who cannot be followed up .
  • Children who have taken the appropriate doses of WHO-recommended dose of anti microbial drug for 48 hours prior to presentation .
  • Children who have prior history of wheezing or bronchial asthma and are wheezing now .
  • Children whose parents or guardians refuse to give consent.
  • Previously enrolled patients in the present study.
  • Hospitalization in the past two weeks.

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 identifier (NCT number): NCT01375426

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ARI Research Cell, Children Hospital, Pakistan Institute of Medical Sciences
Islamabad, Capital, Pakistan, 44000
Sponsors and Collaborators
ARI Research Cell
World Health Organization
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Principal Investigator: Tabish Hazir, Fellowship Children Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan

Layout table for additonal information Identifier: NCT01375426     History of Changes
Other Study ID Numbers: DDAMOXI
First Posted: June 17, 2011    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: June 2011

Keywords provided by ARI Research Cell:
Non-severe pneumonia
Treatment failure
Double dose amoxicillin

Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents