Improved Management and in-Hospital Mortality

Malaria Clinical Trial

— MTV  

Official title:

Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465777
• Other study ID #: PED-MTV-2004
• Status: Completed
• Phase: N/A
• First received: April 23, 2007
• Last updated: April 23, 2007
• Start date: December 2004
• Est. completion date: February 2006

Study information

• Verified date: April 2007
• Source: Bandim Health Project
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guinea-Bissau: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 950
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

Inclusion Criteria:

• Hospitalization due to malaria

• Non per os

Exclusion Criteria:

• Consent from parent/caretaker declined

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Malaria
• Mortality

Intervention

Behavioral:
• Guideline adherence and financial incentive

Locations

Country	Name	City	State
Guinea-Bissau	Bandim Health Project	Bissau

Sponsors (3)

Lead Sponsor	Collaborator
Bandim Health Project	Statens Serum Institut, World Health Organization

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital case-fatality
Secondary	Cumulative post-discharge mortality on day 28 and length of hospitalisation