Trial in Childhood Pneumonia With Malnutrition

NCT00968370 | Completed Phase 4 DMC

• 1 other identifier: 2008-009
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malnutrition; Pneumonia

Keywords

Severe and very severe pneumonia; severe malnutrition; children; day-care management; hospital management

Outcome Measures

Primary Outcomes (1)

• Proportion of success with 95% confidence interval (CI)

  3 years

Secondary Outcomes (7)

• Case fatality rate with 95% CI -day-care clinic/hospital

  3 years

• Proportion of failure rate with 95% CI

  3 years

• Duration of illness (d)

  3 years

• Proportion of referral & discontinuation with 95% CI

  3 years

• Duration of success (d)

  3 years

Study Arms (2)

Day-care clinic

ACTIVE COMPARATOR

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

Hospital management

OTHER

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

Interventions

Day-care clinic OTHER

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.

Day-care clinic

Hospital Management OTHER

Inj. Ceftriaxone and other micronutrients will be given to children at the hospital from admission till discharge.

Hospital management

Eligibility Criteria

• Age: 2 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of Basel: collaborator
• Institute of Child health & Shishu Sasthya Foundation Hospital (ICHSH), Bangladesh: collaborator
• Radda MCH-FP Centre, Bangladesh: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Ashraf H, Alam NH, Sultana M, Jahan SA, Begum N, Farzana S, Chisti MJ, Kamal M, Shamsuzzaman A, Ahmed T, Khan JAM, Fuchs GJ, Duke T, Gyr N. Day clinic vs. hospital care of pneumonia and severe malnutrition in children under five: a randomised trial. Trop Med Int Health. 2019 Jul;24(7):922-931. doi: 10.1111/tmi.13242. Epub 2019 May 14.

  PMID: 31046165 DERIVED

MeSH Terms

Conditions

Malnutrition; Pneumonia

Interventions

Hospital Administration

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Facility Administration; Health Facilities; Health Care Facilities Workforce and Services; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: November 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 16, 2013

Record last verified: 2009-08

Locations

BA (1)