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

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ClinicalTrials.gov Identifier: NCT01002066
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : November 15, 2011
Sponsor:
Collaborators:
Zanzibar Malaria Control Programme
World Health Organization
Information provided by (Responsible Party):
Anders Björkman, Karolinska University Hospital

Brief Summary:
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.

Condition or disease
Fever Malaria

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.


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Study Type : Observational
Actual Enrollment : 3890 participants
Observational Model: Cohort
Official Title: 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
Study Start Date : May 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Malaria




Primary Outcome Measures :
  1. Adherence to Rapid diagnostic tests (RDT) result [ Time Frame: Five months ]

Biospecimen Retention:   Samples With DNA
Whole blood collected on Rapid diagnostic tests (RDT)s and Filter paper (FP)


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT01002066


Locations
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Tanzania
Primary health care centers (PHCC)s and Primary health care units (PHCUs)
Kivunge and Micheweni, Zanzibar, Tanzania
Sponsors and Collaborators
Karolinska University Hospital
Zanzibar Malaria Control Programme
World Health Organization
Investigators
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Principal Investigator: Anders Björkman, Professor Karolinska University Hopsital
Principal Investigator: Andreas Mårtensson, Ph.D, M.D. Karolinska University Hospital
Principal Investigator: Kristina Elfving, M.D. Karolinska University Hospital
Principal Investigator: Mwinyi Msellem, MSc Zanzibar Malaria Control Programme
Principal Investigator: Delér Shakely, M.D. Karolinska University Hopsital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anders Björkman, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01002066     History of Changes
Other Study ID Numbers: ACT2010
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011

Keywords provided by Anders Björkman, Karolinska University Hospital:
Fever
Malaria
RDT
IMCI
Children<5 years of age
ACT

Additional relevant MeSH terms:
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Malaria
Fever
Protozoan Infections
Parasitic Diseases
Body Temperature Changes
Signs and Symptoms