Improved Management and in-Hospital Mortality (MTV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00465777
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : April 25, 2007
Statens Serum Institut
World Health Organization
Information provided by:
Bandim Health Project

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
Mortality Malaria Behavioral: Guideline adherence and financial incentive

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
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 : December 2004
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. In-hospital case-fatality

Secondary Outcome Measures :
  1. Cumulative post-discharge mortality on day 28 and length of hospitalisation

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00465777

Bandim Health Project
Bissau, Guinea-Bissau, 1004
Sponsors and Collaborators
Bandim Health Project
Statens Serum Institut
World Health Organization
Study Chair: Peter Aaby, DMSc Bandim Health Project

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00465777     History of Changes
Other Study ID Numbers: PED-MTV-2004
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: April 25, 2007
Last Verified: April 2007

Keywords provided by Bandim Health Project:

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases