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

This study has been completed.
Sponsor:
Collaborators:
Indira Gandhi Medical College
International Clinical Epidemiology Network (INCLEN) TRUST
MCH-STAR Initiative, India
Information provided by:
Lata Medical Research Foundation, Nagpur
ClinicalTrials.gov Identifier:
NCT01386840
First received: June 25, 2011
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Pneumonia
Other: Severe Pneumonia - Home Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IndiaCLEN Multicentric Trial of Home Versus Hospital Oral Amoxicillin for Management of Severe Pneumonia in Children

Resource links provided by NLM:


Further study details as provided by Lata Medical Research Foundation, Nagpur:

Primary Outcome Measures:
  • 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 [ Time Frame: Day of enrollment to Day 7 ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • 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 [ Time Frame: Day 8 to Day 14 ] [ Designated as safety issue: Yes ]

    Secondary outcome of this trial are to determine 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
    • To identify clinical predictors at baseline and during the course of treatment that predicts "failure of oral treatment",
    • The costs of home and hospital management of severe pneumonia with oral amoxycillin.
    • Left against medical advice (LAMA)
    • Loss to follow up from day 8th to day 14th.


Enrollment: 1118
Study Start Date: January 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Severe Pneumonia - Hospital Management

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"

Other: Severe Pneumonia - Home Management

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.

Experimental: Severe Pneumonia - Home Management

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

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.


Detailed 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.
  Eligibility

Ages Eligible for Study:   3 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
  • Previous inclusion in the study or already included in another study
  • Living outside a pre-defined area
  • Parental or caretaker refusal to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386840

Locations
India
Indira Gandhi Govt. Medical College, Nagpur
Nagpur, Maharashtra, India, 440018
B.J. Medical College, Pune
Pune, Maharashtra, India
Mahatma Gandhi Institute of Medical Sciences, Sevagram
Wardha, Maharashtra, India
Institute of Child Health, Chennai
Chennai, Tamilnadu, India
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh, Uttar Pradesh, India
Post Graduate Institute of Medical Sciences, Chandigarh
Chandigarh, India
Sponsors and Collaborators
Lata Medical Research Foundation, Nagpur
Indira Gandhi Medical College
International Clinical Epidemiology Network (INCLEN) TRUST
MCH-STAR Initiative, India
Investigators
Principal Investigator: Archana B Patel, MD,DNB,PhD Professor And Head, Pediatrics, Indira Gandhi Govt. Medical College & CEO and Vice President, Lata MEdical Research Foundation, Nagpur
  More Information

No publications provided

Responsible Party: Dr. Archana Patel, Principal Investigator & Professor & Head Pediatrics, Indira Gandhi Govt. Medical College & Lata Medical REsearch Foundation, Nagpur
ClinicalTrials.gov Identifier: NCT01386840     History of Changes
Other Study ID Numbers: 02_ISPOT
Study First Received: June 25, 2011
Last Updated: June 30, 2011
Health Authority: India: IndiaCLEN Institutional Review Board

Keywords provided by Lata Medical Research Foundation, Nagpur:
Efficacy of Treatment
Severe
home treatment
treatment at hospital

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014