Indiaclen Short Course Amoxycillin Therapy for Pneumonia With Wheeze

NCT00407394 | Completed Phase 3

• 1 other identifier: 9998
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The current Integrated management of childhood infections (IMCI) algorithm prescribes that children with wheeze and fast breathing presenting to first level health facilities are given antibiotics if they continue to have fast breathing after two doses of bronchodilator. The primary purpose of the algorithm is to prevent mortality due to bacterial pneumonia. However, an unknown proportion of children managed in this fashion will have a viral related wheezing illness or asthma rather than pneumonia. Although it is unlikely that wheezing syndromes are a significant cause of mortality for children in developing countries, these algorithms are likely to result in unnecessary administration of antibiotics as well as inadequate treatment of recurrent wheezing illness. We do not have clear evidence about whether antibiotics can be withheld in some categories of children with wheeze. It is clear that wheeze can occur in bacterial infection and in addition co-infection with virus and bacteria has been well demonstrated in several studies of pneumonia etiology in children. Although some studies have found that children with more severe disease or who are blood culture positive are more likely to be febrile at presentation, this sign is not sufficiently sensitive or specific to determine whether antibiotics should be administeredSetting: The study will be conducted in eight medical colleges situated in Lucknow, Nagpur, New Delhi, Mumbai, Chennai, Trivandrum, Vellore, and Chandigarh. Design: This will be a multicentric, randomized, double blind efficacy trial. . Hypothesis: The primary hypothesis is that the use of oral amoxycillin for three days would be as effective, in terms of clinical cure on day 4 as compared to use of oral placeboMain objective: To compare the proportion of children aged 2 to 59 months presenting with non-severe pneumonia with wheeze whose respiratory rate does not fall below the age specific cut-off after three doses of nebulized salbutamol, that achieve clinical cure on day 4 on 3 day of treatment with oral amoxycillin versus placebo.Inclusion criteria: Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off, audible / ausculatory wheeze. Exclusion criteria: Children with severe disease, received any documented antibiotic treatment in the past 48 hours, diagnosed asthmatic on maintenance therapy, complicating acute non-pulmonary or chronic illness, known drug allergy, hospitalization in the past 2 weeks, history of measles within the last month, known immunodeficiency disorder, prior enrollment in the study, residing in areas not accessible for follow-up or whose guardian refuses to consent for the study. Sample size: Has been calculated to test the null hypothesis. There will be 950 children in each arm. Thus each site is required to recruit a minimum of 225 cases over 18 months.

Conditions

Non-Severe Pneumonia With Wheeze

Keywords

Pneumonia; Wheezing; Treatment; Children; India

Outcome Measures

Primary Outcomes (1)

• Clinical Cure: Respiratory rate below age specific cut-off (<50 bpm in infants <12 months and <40 bpm in 12 - 59 months of age).

Secondary Outcomes (1)

• Clinical failure: Any signs of severe pneumonia or severe disease; chest in drawing, convulsions, drowsiness or inability to drink at any time; Respiratory rate above age specific cut-off on day 4 or after that; Oxygen saturation on pulse oximetry <90%

Interventions

Amoxycillin DRUG

Eligibility Criteria

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

You may qualify if:

• Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off, audible / ausculatory wheeze, accessible to follow up, whose guardians give written informed consent.

You may not qualify if:

• Children with severe disease, received any documented antibiotic treatment in the past 48 hours, diagnosed asthmatic on maintenance therapy, complicating acute non-pulmonary or chronic illness, known drug allergy, hospitalization in the past 2 weeks, measles or history of measles within the last month, known immunodeficiency disorder, prior enrollment in the study, residing in areas not accessible for follow-up or whose guardian refuses to consent for the study. Radiological Pneumonia on X-Ray.

Sponsors & Collaborators

• King George's Medical University: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

King George's Medical University

Lucknow, Uttar Pradesh, 226003, India

Location

Related Publications (1)

• Awasthi S, Agarwal G, Kabra SK, Singhi S, Kulkarni M, More V, Niswade A, Pillai RM, Luke R, Srivastava NM, Suresh S, Verghese VP, Raghupathy P, Lodha R, Walter SD. Does 3-day course of oral amoxycillin benefit children of non-severe pneumonia with wheeze: a multicentric randomised controlled trial. PLoS One. 2008 Apr 23;3(4):e1991. doi: 10.1371/journal.pone.0001991.

  PMID: 18431478 DERIVED

MeSH Terms

Conditions

Pneumonia; Respiratory Sounds

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Shally Awasthi, MD

  King George's Medical University, Lucknow, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2006
• First Posted: December 5, 2006
• Study Start: April 1, 2004
• Study Completion: April 1, 2006
• Last Updated: December 5, 2006

Record last verified: 2006-12

Locations

IN (1)