MTV: Improved Management and in-Hospital Mortality

• Sponsor: Bandim Health Project (Other)
• Overall Status: Completed
• CT.gov ID: NCT00465777
• Collaborator: Statens Serum Institut (Other), World Health Organization (Other)
• Enrollment: 950
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 67.7

Study Details

Study Description

Brief Summary

The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.

Condition or Disease	Intervention/Treatment	Phase
Mortality; Malaria	Behavioral: Guideline adherence and financial incentive	N/A

Detailed Description

Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial
• Study Start Date: Dec 1, 2004
• Actual Study Completion Date: Feb 1, 2006

Outcome Measures

Primary Outcome Measures

1. In-hospital case-fatality []

Secondary Outcome Measures

1. Cumulative post-discharge mortality on day 28 and length of hospitalisation []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Hospitalization due to malaria

• Non per os

Exclusion Criteria:

• Consent from parent/caretaker declined

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bandim Health Project	Bissau		Guinea-Bissau	1004

Sponsors and Collaborators

• Bandim Health Project
• Statens Serum Institut
• World Health Organization

Investigators

• Study Chair: Peter Aaby, DMSc, Bandim Health Project

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00465777
• Other Study ID Numbers: PED-MTV-2004
• First Posted: Apr 25, 2007
• Last Update Posted: Apr 25, 2007
• Last Verified: Apr 1, 2007

• Keywords provided by , ,: malaria; mortality; hospital; incentive; personnel; paediatric
• Additional relevant MeSH terms: Malaria

Study Results

No Results Posted as of Apr 25, 2007