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

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by:
ARI Research Cell
ClinicalTrials.gov Identifier:
NCT01375426
First received: June 16, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.

Hypothesis:

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 Intervention Phase
Pneumonia
Drug: Oral amoxicillin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by ARI Research Cell:

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

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

Estimated Enrollment: 900
Study Start Date: September 2003
Estimated Study Completion Date: June 2004
  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:

  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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01375426

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

No publications provided

ClinicalTrials.gov Identifier: NCT01375426     History of Changes
Other Study ID Numbers: DDAMOXI
Study First Received: June 16, 2011
Last Updated: June 16, 2011
Health Authority: Pakistan: Ethical Review Board, Pakistan Institute of Medical Sciences

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

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

ClinicalTrials.gov processed this record on September 18, 2014