Effectiveness Of Rapid Diagnostic Tests in the New Context of Low Malaria Endemicity in Zanzibar (RDTACT)

November 14, 2011 updated by: Anders Björkman, Karolinska University Hospital

Rapid Malaria Diagnostic Tests in Fever Patients Attending Primary Health Care Facilities in Zanzibar - Effectiveness as Diagnostic and Surveillance Tool in the New Context of Low Malaria Endemicity

The purpose of this study is to study the effectiveness of wide scale RDT use at the primary health care level in previously high malaria endemic area during malaria pre-elimination phase for improved targeting of anti-malarial drugs, malaria surveillance and epidemic alertness.

Study Overview

Status

Completed

Conditions

Detailed Description

During the last 6 years Zanzibar has undergone a dramatic change in malaria epidemiology and burden of disease, with a marked decline of Plasmodium falciparum malaria among febrile children from approximately 30% to 1% or below and a reduction of crude child mortality of 50% Overuse of the expensive ACTs will not only be a substantial financial burden on the health care system in Zanzibar, but will also spur anti-malarial drug resistance with devastating effect on global malaria control efforts and prevent other causes of fever from being appropriately treated, e.g. pneumonias which require antibiotics. Rapid Diagnostic Tests (RDTs), based on antigen detection of P. falciparum, are proposed as a future cornerstone to improve diagnostic efficiency also at the peripheral health care level beyond the reach of microscopy services

IMCI algorithms based on clinical symptoms could potentially be made more efficient and cost effective if simple parasitological diagnostic methodologies were incorporated. Zanzibar is among the first regions to incorporate RDT in the IMCI guidelines in Africa, which provides a unique research opportunity to scientifically evaluate the effectiveness of incorporating RDT in the existing IMCI algorithm.

Another key challenge for Zanzibar is to monitor potential development of parasite resistance to ACT when the number of malaria positive patients is insufficient to conduct standard in vivo efficacy trials. We propose that RDT could play a critical new role also in this regard.

Study Type

Observational

Enrollment (Actual)

3890

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
    • Zanzibar
      • Kivunge and Micheweni, Zanzibar, Tanzania
        • Primary health care centers (PHCC)s and Primary health care units (PHCUs)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary health care units (PHCUs) and Primary health care centres (PHCCs) in North A and Micheweni Districts in Zanzibar

Description

Inclusion Criteria:

  • All patients >2 months of age with confirmed fever, with a measured axillary temperature of ≥37.5˚C, or history of fever within the preceding 24 hours
  • Presenting to the health facility from 8.00 to 16.00 Monday to Friday.
  • Informed consent

Exclusion Criteria:

  • Previous enrolment in the study within the last 28 days.
  • Severe disease that requires immediate referral as defined by the clinician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adherence to Rapid diagnostic tests (RDT) result
Time Frame: Five months
Five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

World Health Organization
Zanzibar Malaria Control Programme

Investigators

  • Principal Investigator: Anders Björkman, Professor, Karolinska University Hopsital
  • Principal Investigator: Mwinyi Msellem, MSc, Zanzibar Malaria Control Programme
  • Principal Investigator: Delér Shakely, M.D., Karolinska University Hopsital
  • Principal Investigator: Andreas Mårtensson, Ph.D, M.D., Karolinska University Hospital
  • Principal Investigator: Kristina Elfving, M.D., Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

November 15, 2011

Last Update Submitted That Met QC Criteria

November 14, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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