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

NCT01375426 | Completed Phase 1

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

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. 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

Non-severe pneumonia; Treatment failure; Double dose amoxicillin; Children

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (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.

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 (Table 1).

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 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.

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

  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: June 16, 2011
• First Posted: June 17, 2011
• Study Start: September 1, 2003
• Study Completion: June 1, 2004
• Last Updated: June 17, 2011

Record last verified: 2011-06

Locations

PA (1)