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Efficacy of Single Versus Double Dose of Oral Amoxicillin for Non-Severe Pneumonia in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130013
First Posted: August 15, 2005
Last Update Posted: December 9, 2005
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.
Collaborator:
World Health Organization
Information provided by:
ARI Research Cell
  Purpose

The World Health Organization’s (WHO) standard case management strategy for reducing acute respiratory infection (ARI) related mortality recommends oral cotrimoxazole and oral amoxicillin as first line drugs for the treatment of pneumonia. In 1989, the Pakistan Ministry of Health (MOH) adopted this strategy to control ARI mortality and recommended cotrimoxazole for treatment of outpatients pneumonia due to lower costs. A number of studies subsequently performed have shown significant in vivo and in vitro resistance of H. influenzae and S. pneumoniae, the commonest bacteria causing childhood pneumonia, to cotrimoxazole.

Although on a case by case basis for pneumonia, in vitro resistance does not correlate very well with in vivo failures, nevertheless, clinical failure rate for pneumonia therapy has increased in Pakistan over the years. One can hypothesize that if bacterial pneumonia is a certain proportion of all pneumonia cases, the rise in clinical failures may be related to increasing antimicrobial resistance. Therefore, it is probable that this rising clinical failure rate could be a reflection of increasing resistance. There may be an increase in antimicrobial resistance of S. pneumoniae and H. influenzae to amoxicillin over the period of years and the rising treatment failure could be a reflection of the rising minimum inhibitory concentrations (MIC’s) (> 2 mcg/ml for H. influenzae, 1993-94), thereby, resulting in this increasing failure rate.

For the current study the researchers propose a multicentre, randomized, controlled double blind trial in which standard versus double dose oral amoxicillin for three days for the treatment of non-severe pneumonia in children less than five years of age will be compared.

Primary Objective:

To compare the proportion of children 2 – 59 months of age presenting with non-severe pneumonia, who achieve clinical resolution on day 5 with standard (15 mg/kg/8hrly) versus double dose (30 mg/kg/8hrly) of oral amoxicillin therapy given for 3 days.

Secondary Objective:

To follow the clinical course of non-severe pneumonia with the alternative criteria of treatment failure (signs of deterioration i.e. lower chest indrawing and appearance of danger signs) on or before day 3 and compare them with other children who have persistent fast breathing (respiratory rate above the cut off for age) on day 3.

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
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

Resource links provided by NLM:


Further study details as provided by ARI Research Cell:

Primary Outcome Measures:
  • To compare standard vs double dose of oral amoxicillin for non-severe pneumonia in children < 5 age.

Secondary Outcome Measures:
  • To use modified treatment failure criteria on or before day 3 and compare them with WHO criteria for failure.

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

  Eligibility

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:

  • They are aged 2-59 months.
  • Diagnosed with WHO defined non-severe pneumonia

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 antimicrobial 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
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): NCT00130013


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 ARI Research Cell, Children Hospital, Pakistan Institute of Medical Sciences, Islamabad, Pakistan
  More Information

ClinicalTrials.gov Identifier: NCT00130013     History of Changes
Other Study ID Numbers: DDoseAmoxy
First Submitted: August 12, 2005
First Posted: August 15, 2005
Last Update Posted: December 9, 2005
Last Verified: July 2004

Keywords provided by ARI Research Cell:
Children
Non-severe pneumonia
Oral amoxicillin

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