Trial in Childhood Pneumonia With Malnutrition

This study has been completed.
Sponsor:
Collaborators:
University of Basel
Institute of Child health & Shishu Sasthya Foundation Hospital (ICHSH), Bangladesh
Radda MCH-FP Centre, Bangladesh
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00968370
First received: August 28, 2009
Last updated: July 14, 2013
Last verified: August 2009
  Purpose

The impetus for this study came from the findings of the investigators' recently published study entitled "Day-care management of severe and very severe pneumonia, without associated co-morbidities such as severe malnutrition, in an urban health clinic in Dhaka, Bangladesh". If day-care management is found to have comparable efficacy to that of hospital management of severe and very severe pneumonia in children then they could be managed at outpatient, day-care set ups reducing hospitalization and thus freeing beds for management of other children who need hospital care. Such management could also be implemented in rural areas of Bangladesh and potentially to other developing countries. Additionally, availability of the treatment facility in community set-ups will be cost and time saving for the population. But, as patients with severe malnutrition were excluded from the pilot study for ethical reasons, the peer reviewers of the manuscript felt that the study findings cannot be applied to the treatment of severe and very severe pneumonia in general. Similarly, management of severely malnourished children with associated complications relies on hospital-based treatment. In another study, a day-care clinic approach by providing antibiotics, micronutrients, diet and supportive care to severely malnourished children showed that they could be successfully managed at existing day-care clinics using a protocolized approach. Therefore, after the successful conduction and publication of these two study results in international journals with severe and very severe pneumonia as well as severe malnutrition at the day-care clinic, it is mandatory to perform the final study where the investigators will include severe malnutrition as well as associated co-morbidities to be applied to the treatment of severe and severe pneumonia in children in general to make the treatment approach more widely applicable.


Condition Intervention Phase
Malnutrition
Pneumonia
Other: Day-care clinic
Other: Hospital Management
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Controlled Clinical Trial of Day-care Based and Hospitalized Management of Severe and Very Severe Pneumonia, With Severe Malnutrition, With/Without Associated Co-morbidities in Children

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Proportion of success with 95% confidence interval (CI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Case fatality rate with 95% CI -day-care clinic/hospital [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Proportion of failure rate with 95% CI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Duration of illness (d) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Proportion of referral & discontinuation with 95% CI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Duration of success (d) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Development of complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cost of treatment [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 440
Study Start Date: November 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Day-care clinic
Inj. Ceftriaxone and other micronutrients will be given to children at the day-care clinic from 8:00 a.m. to 5:00 p.m. daily.
Other: Day-care clinic
Inj. Ceftriaxone and other micronutrients will be given to children at the day-care clinic from 8:00 a.m. to 5:00 p.m. daily.
Hospital management
Hospital management: all children admitted at the hospital will be managed with injection Ceftriaxone and other micronutrients for the total duration of hospitalization as per approved protocol.
Other: Hospital Management
Inj. Ceftriaxone and other micronutrients will be given to children at the hospital from admission till discharge.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 2 to 59 months
  • Sex: Both boys and girls
  • Severe and very severe pneumonia
  • Severe malnutrition (defined as < - 3 weight-for-height Z-score)
  • Attending Radda Clinic or ICHSH between 8:00 to 16:00
  • Written informed consent by respective parents/guardians

Exclusion Criteria:

  • Non-severe pneumonia
  • Nosocomial pneumonia
  • Bronchiolitis
  • Bronchial asthma
  • Living long distance (>5 km) from the Radda Clinic and ICHSH
  • Visits during late hours of the day (after 16:00)
  • Parents/guardians not consenting for enrolment of children in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00968370

Locations
Bangladesh
International Centre for Diarrhoeal Disease Research Bangladesh
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Basel
Institute of Child health & Shishu Sasthya Foundation Hospital (ICHSH), Bangladesh
Radda MCH-FP Centre, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT00968370     History of Changes
Other Study ID Numbers: 2008-009
Study First Received: August 28, 2009
Last Updated: July 14, 2013
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Severe and very severe pneumonia
severe malnutrition
children
day-care management
hospital management

Additional relevant MeSH terms:
Pneumonia
Malnutrition
Nutrition Disorders
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014