Trial of Rapid Diagnostic Tests in Rural Ghana - Full Text View

Trial of Rapid Diagnostic Tests in Rural Ghana (RDT)

This study is not yet open for participant recruitment.

Verified by Gates Malaria Partnership, June 2007

Sponsors and Collaborators:	Gates Malaria Partnership Ghana Health Services London School of Hygiene and Tropical Medicine
Information provided by:	Gates Malaria Partnership
ClinicalTrials.gov Identifier:	NCT00493922

Purpose

1) To compare in a setting where microscopy for malaria is available whether introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v microscopy). 2) To compare whether, in a setting where microscopy for malaria is not available, introducing rapid diagnostic tests (RDTs) improves targetting of antimalarial drugs and antibiotics (RDT v clinical diagnosis).

Condition	Intervention	Phase
Malaria Bacterial Infections	Device: Rapid diagnostic test	Phase IV

MedlinePlus related topics: Bacterial Infections Malaria

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana

Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:

The proportion of RDT test-negative patients who are prescribed an antimalarial in two settings: where there is microscopy and where diagnosis is on clinical basis [ Time Frame: Two years ]

Secondary Outcome Measures:

Proportion of RDT test-positive patients who were not prescribed an antimalarial in both settings [ Time Frame: Two years ]
Proportion of clinic microscopy slide-negative patients who were prescribed an anti-malarial in the setting with microscopy available [ Time Frame: Two years ]
Proportion of patients receiving additional or alternative treatments to antimalarials following a negative RDT result and which treatments these are. [ Time Frame: Two years ]

Estimated Enrollment:	6500
Study Start Date:	July 2007
Estimated Study Completion Date:	June 2009

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinician decision to test for malaria

Exclusion Criteria:

Pregnant women
Severe malaria requiring referral
Patient refuses consent
Clinician specifically requests for microscopy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493922

Contacts

Contact: Evelyn K Ansah, MD MPH PhD		evelyn.ansah@lshtm.ac.uk
Contact: Christopher JM Whitty, FRCP		christopher.whitty@lshtm.ac.uk

Locations

Ghana, Greater Accra
Dangme West District
Dodowa, Greater Accra, Ghana

Sponsors and Collaborators

Gates Malaria Partnership

Ghana Health Services

London School of Hygiene and Tropical Medicine

Investigators

Principal Investigator:

Evelyn K Ansah, MD MPH PhD

Ghana Health Services

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	REG-8
Study First Received:	June 28, 2007
Last Updated:	June 28, 2007
ClinicalTrials.gov Identifier:	NCT00493922
Health Authority:	Ghana: Ministry of Health

Keywords provided by Gates Malaria Partnership:

Malaria
Diagnosis
Rapid diagnostic tests

Microscopy
Clinical diagnosis
Africa

Study placed in the following topic categories:

Bacterial Infections
Protozoan Infections
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Coccidiosis
Infection

ClinicalTrials.gov processed this record on January 16, 2009