IndiaCLEN Multicentre Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children — ISPOT  

Pneumonia Clinical Trial

Official title: IndiaCLEN Multicentric Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of oral amoxicillin in treating WHO defined severe pneumonia(cough and fast breathing with lower chest indrawing) at home and at hospital using an open labelled multicentric prospective two-arm randomized clinical trial to determine the differences in failure of treatment with a 7 day course of oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent home after enrolment, in children 3 to 59 months old who have severe pneumonia. The investigators developmental hypothesis were to test whether the community/home based oral amoxicillin is efficacious for treating severe pneumonia.

Clinical Trial Description

Primary objectives of this trial are to assess the rates of treatment failure (as defined below) within the first 7 days or efficacy of a 7 day course of oral amoxycillin when administered at home in comparison to administration of oral amoxycillin for first 48 hours in the hospital.

Treatment failure is defined as follows-

• Clinical deterioration of disease any time after enrollment: developing any sign of very severe disease such as persistent vomiting (vomiting repeated thrice within an hour due to any reason), central cyanosis, grunt, stridor, abnormally sleepy or difficult to wake, inability to drink, convulsions, or death.

• Change of antibiotic: due to persistent vomiting (vomiting of amoxycillin within 20 minutes of administration; 3 such attempts), or, developing a co-morbid condition, or persisting fever > 98.6°F with lower chest indrawing even after 3rd day, or, fever alone at or after day 5, or, lower chest indrawing alone (non responsive to three doses of nebulization with bronchodilator) at or after day 5(as reported by the mother), or, persistence of fast breathing after day 7 which is non responsive to three doses of nebulisation with bronchodilator.

• Hospitalization: any time in home managed patients or clinical decision to extend the hospitalization longer than 48 hours in hospitalized children or re-hospitalization in those discharged after 48 hours from hospital. It could be related to pneumonia, or to therapy with amoxycillin [relatedness determined by the Data & Safety Monitoring Board (DSMB)].

• Children who need to restart antibiotics i.e. "failure of treatment", between day 8th and day 14th due to reappearance of any danger signs, lower chest indrawing or fast breathing which is non responsive to three trials of nebulization with bronchodilator.

• Serious adverse event considered possibly or probably related to amoxycillin.

• Left against medical advice (LAMA) or Voluntary withdrawal of consent from study from enrollment uptill day 14th.

• Loss to follow up uptill day 14th.

Secondary objectives of this trial are to determine in children receiving oral amoxycillin for severe pneumonia, the following:

• Determine the proportion of children who need to restart antibiotics i.e. "failure of treatment", between day 8th and day 14th due to reappearance of any danger signs, lower chest indrawing or fast breathing which is non responsive to three trials of nebulization with bronchodilator.

• To identify clinical predictors at baseline and during the course of treatment that predicts "failure of oral treatment", from enrollment till day 14th.

• The costs of home and hospital management of severe pneumonia with oral amoxycillin.

• Left against medical advice (LAMA) or Voluntary withdrawal of consent from day 7th to day 14th.

• Loss to follow up from day 8th to day 14th. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia

• NCT number: NCT01386840
• Study type: Interventional
• Source: Lata Medical Research Foundation, Nagpur
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Completion date: April 2011