Clinical trial NCT01002066: Effectiveness Of Rapid Diagnostic Tests in the New Context of Low Malaria Endemicity in Zanzibar
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Malaria
Keywords: Fever
Malaria
RDT
IMCI
Children<5 years of age
ACT
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Zanzibar Malaria Control Programme
name: World Health Organization
First posted: 2009-10-27
Enrollment: 3890
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Adherence to Rapid diagnostic tests (RDT) result
timeFrame: Five months
Secondary outcomes:
Other outcomes:
Locations:
city: Kivunge and Micheweni
country: Tanzania
facility: Primary health care centers (PHCC)s and Primary health care units (PHCUs)
state: Zanzibar
Study officials:
affiliation: Karolinska University Hopsital
name: Anders Björkman, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Andreas Mårtensson, Ph.D, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Kristina Elfving, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zanzibar Malaria Control Programme
name: Mwinyi Msellem, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hopsital
name: Delér Shakely, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shakely D, Elfving K, Aydin-Schmidt B, Msellem MI, Morris U, Omar R, Weiping X, Petzold M, Greenhouse B, Baltzell KA, Ali AS, Bjorkman A, Martensson A. The usefulness of rapid diagnostic tests in the new context of low malaria transmission in Zanzibar. PLoS One. 2013 Sep 4;8(9):e72912. doi: 10.1371/journal.pone.0072912. eCollection 2013.