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

NCT00130013 | Completed Phase 1

• 1 other identifier: DDoseAmoxy
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia

Keywords

Children; Non-severe pneumonia; Oral amoxicillin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Oral Amoxicillin DRUG

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARI Research Cell: lead
• World Health Organization: collaborator

Study Sites (1)

ARI Research Cell, Children Hospital, Pakistan Institute of Medical Sciences

Islamabad, Capital, 44000, Pakistan

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tabish Hazir, Fellowship

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: September 1, 2003
• Study Completion: June 1, 2004
• Last Updated: September 23, 2005

Record last verified: 2004-07

Locations

PA (1)