NCT01386840

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,118

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2011

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

3.2 years

First QC Date

June 25, 2011

Last Update Submit

May 15, 2015

Conditions

Pneumonia

Keywords

Efficacy of TreatmentSeverehome treatmenttreatment at hospital

Outcome Measures

Primary Outcomes (1)

  • To assess the 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

    Primary outcomes are to assess the 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, on the following study outcomes, the presence of any one of which indicate "failure of treatment" : * Clinical deterioration of disease any time after enrollment * Change of antibiotic * Hospitalization * Serious adverse event considered possibly or probably related to amoxycillin. * Left against medical advice (LAMA) * Loss to follow up on day 8th

    Day of enrollment to Day 7

Secondary Outcomes (1)

  • To determine factors leading to treatment failure from day 8 to day 14 and costs of home and hospital management of severe pneumonia with oral amoxycillin

    Day 8 to Day 14

Study Arms (2)

Severe Pneumonia - Hospital Management

NO INTERVENTION

Those randomized to hospital management will be monitored by health personnel for at least 48 hours for clinical deterioration and parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, Clinical deterioration, Other signs eg. comorbid conditions, Assessment of adherence, Adverse event. Mothers, whose children are discharged after 48 hours, will be counseled to continue with oral treatment prescribed for a period of 7 days and will be advised to return to healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the "patient discharge counselling checklist". Mothers will be given a "study patient data card"

Severe Pneumonia - Home Management

EXPERIMENTAL

For those randomized to home management, first dose will be administered by the mother/caretaker under supervision at health facility. The health personnel will assess the parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, clinical deterioration, Other signs eg. co-morbid conditions, Assessment of adherence, Adverse event when they visit the home after 24 hours, 72 hours and on day 8th. Mothers will be advised to return to the healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the "patient discharge counselling checklist". Mothers will be given a "study patient data card" with contact Numbers.

Other: Severe Pneumonia - Home Management

Interventions

Severe Pneumonia - Home ManagementOTHER

For those randomized to home management, first dose will be administered by the mother/caretaker under supervision at health facility. The health personnel will assess the parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, clinical deterioration, Other signs eg. co-morbid conditions, Assessment of adherence, Adverse event when they visit the home after 24 hours, 72 hours and on day 8th. Mothers will be advised to return to the healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the "patient discharge counselling checklist". Mothers will be given a "study patient data card" with contact Numbers.

Severe Pneumonia - Home Management

Eligibility Criteria

Age3 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 3 to 59 months with pneumonia and lower chest wall indrawing
  • Ability to take orally
  • Absence of radiological consolidation or effusion
  • Informed consent by a legal guardian

You may not qualify if:

  • Children with any of the following conditions:
  • Very severe pneumonia/disease
  • Respiratory rate \> 70/min
  • Persistent vomiting
  • Known prior episodes of asthma, or, three or more prior episodes of wheezing
  • LCI that resolves after three doses of bronchodilator therapy1
  • Documented use of prior oral antibiotics for 48 hours
  • Severe malnutrition (weight for height \< 3SD or kwashiorkor)
  • Known penicillin or amoxicillin allergy
  • Hospitalization in the last two weeks
  • Known or clinically recognizable HIV, congenital cardiac or respiratory anomalies, chronic lung disease including bronchopulmonary dysplasia, neurological impairment that affects respiratory function, renal diseases, malignant or haematological diseases.
  • Other diseases requiring antibiotic therapy at presentation, such as meningitis,dysentery, osteomyelitis, septic arthritis, evident tuberculosis, etc.
  • Anaemia requiring blood transfusion
  • Kerosene poisoning
  • Measles in the last 15 days
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Post Graduate Institute of Medical Sciences, Chandigarh

Chandigarh, Chandigarh, India

Location

Indira Gandhi Govt. Medical College, Nagpur

Nagpur, Maharashtra, 440018, India

Location

B.J. Medical College, Pune

Pune, Maharashtra, India

Location

Mahatma Gandhi Institute of Medical Sciences, Sevagram

Wardha, Maharashtra, India

Location

Institute of Child Health, Chennai

Chennai, Tamil Nadu, India

Location

Jawaharlal Nehru Medical College, Aligarh Muslim University

Aligarh, Uttar Pradesh, India

Location

Related Publications (1)

  • Patel AB, Bang A, Singh M, Dhande L, Chelliah LR, Malik A, Khadse S; ISPOT Study Group. A randomized controlled trial of hospital versus home based therapy with oral amoxicillin for severe pneumonia in children aged 3 - 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study. BMC Pediatr. 2015 Nov 17;15:186. doi: 10.1186/s12887-015-0510-9.

    PMID: 26577943DERIVED

MeSH Terms

Conditions

PneumoniaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Archana B Patel, MD,DNB,PhD

    Professor And Head, Pediatrics, Indira Gandhi Govt. Medical College & CEO and Vice President, Lata MEdical Research Foundation, Nagpur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Pediatrics

Study Record Dates

First Submitted

June 25, 2011

First Posted

July 1, 2011

Study Start

January 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations

IN(6)