Operational Research Management for Children With Severe Pneumonia (OR-pneumonia)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by International Centre for Diarrhoeal Disease Research, Bangladesh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
UNICEF
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01312792
First received: March 8, 2011
Last updated: November 11, 2013
Last verified: March 2011
  Purpose

The investigators Study Hypothesis is introduction of modified IMCI guideline for managing severe pneumonia in first level health facilities will result in 40% increase in the appropriate management (appropriate case management at the first level facility and referral compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to the comparison arm.


Condition Intervention
Pneumonia
Other: Amoxycilline, Cephradine followed by follow up on day 3
Other: Injectable ampicillin followed by urgent referral

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Operational Research on Management at First Level Facilities for Children With Severe Pneumonia

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Proportion of Severe Pneumonia cases approapriately treated as per the Modified IMCI guideline [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    Appropriate management as per modified IMCI guideline denotes Severe pneumonia cases with only chest indrawing and no other danger signs. Such cases will be managed by 1st line oral antiobiotic Amoxicillin by the 1st level health providers. The patient will be asked to come back on 3rd day for follow up when he will be reasessed. If condition improves the antibiotic will be continued for 5 days and if condition deteriorates or remain unchange second line antiobiotic Cephradine will be used. During the treatment if any danger sign appear at any stage the patient will be immediately referred.

  • Proportion of severe pneumonia cases complied appropriately with followup advice given by the health care providers [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    Severe pneumonia cases with only chest indrawing and no other danger signs will be managed by 1st level health providers. In this study the appropriate maangement denotes both treatment with antibiotics and complying with the followup advice given by the health care provider. Following antibiotic prescription, the patient will be asked to come back on 3rd day for follow up when S/he will be reasessed. This is an integral part of the modified IMCI guideline.


Secondary Outcome Measures:
  • Proportion of childhood pneumonia cases treated by trained service provider [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    Following introduction of modified guideline the proportion of childhood pneumonia cases treated by trained service provider as recognized by Govt of Bangladesh will increase in the intervention area.


Estimated Enrollment: 300
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modified IMCI guideline
Modified IMCI Guideline for treating severe phnemonia will be implemented in the arm 1. The Modified IMCI guideline denotes that all severe pneumonia cases with only chest indrawing and no other danger signs will be treated at the first level health facilities with first line oral antibiotics followed by follow-up on 3rd day. On 3rd day the patient will be reassessed and if the condition improves the first line antiobiotic will be continued and if deteriorates or remain unchange second line antibiotic will be used. The patient will be further asked to come on day 3 for reassessment.
Other: Amoxycilline, Cephradine followed by follow up on day 3
Modified IMCI Guideline for treating severe phnemonia will be implemented in the arm 1. The Modified IMCI guideline denotes that all severe pneumonia cases with only chest indrawing and no other danger signs will be treated at the first level health facilities with first line oral antibiotics followed by follow-up on 3rd day. On 3rd day the patient will be reassessed and if the condition improves the first line antiobiotic will be continued and if deteriorates or remain unchange second line antibiotic will be used. The patient will be further asked to come on day 3 for reassessment.
Other Name: Fimoxyl
Active Comparator: Current IMCI guideline
Existing IMCI guideline denotes all severe pneumonia cases will be referred to the 1st level referral facilities after giving first dose of injectable antibiotics
Other: Injectable ampicillin followed by urgent referral
Existing IMCI guideline denotes all severe pneumonia cases will be referred to the 1st level referral facilities after giving first dose of injectable antibiotics
Other Name: Ficillin, ampicillin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe pneumonia with patients of 2 months to 5 years
  • Attending first level health care facilities
  • In Selected study areas

Exclusion Criteria:

  • Any other categories of pneumonia other than severe pneumonia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312792

Contacts
Contact: Shams El Arifeen, DrPH 8860523-32 ext 3800 shams@icddrb.org

Locations
Bangladesh
Union Health Complex Recruiting
Kasiani (Gopalganj) and Sreebordi (Sherpur), Bangladesh
Contact: Shams El Arifeen, DrPH    8860523-32 ext 3800    shams@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
UNICEF
Investigators
Principal Investigator: Shams EL Arifeen, MBBS, DrPH International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01312792     History of Changes
Other Study ID Numbers: PR-10025
Study First Received: March 8, 2011
Last Updated: November 11, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Severe Pneumonia
Pneumonia
ARI
IMCI
Modified IMCI
1st level Health facilities
Children
Operational Research
Bangladesh
Treatment of Severe Pneumonia

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

ClinicalTrials.gov processed this record on April 17, 2014