Improved Management and in-Hospital Mortality (MTV)

This study has been completed.
Sponsor:
Collaborators:
Statens Serum Institut
World Health Organization
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00465777
First received: April 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention
Mortality
Malaria
Behavioral: Guideline adherence and financial incentive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Reduced in-Hospital Mortality After Improved Management of Patients Hospitalised With Malaria. A Randomised Trial

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • In-hospital case-fatality

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

Estimated Enrollment: 950
Study Start Date: December 2004
Study Completion Date: February 2006
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.

  Eligibility

Ages Eligible for Study:   3 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalization due to malaria
  • Non per os

Exclusion Criteria:

  • Consent from parent/caretaker declined
  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: NCT00465777

Locations
Guinea-Bissau
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
  More Information

No publications provided by Bandim Health Project

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00465777     History of Changes
Other Study ID Numbers: PED-MTV-2004
Study First Received: April 23, 2007
Last Updated: April 23, 2007
Health Authority: Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
malaria
mortality
hospital
incentive
personnel
paediatric

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on September 18, 2014