We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial of Rapid Diagnostic Tests in Rural Ghana (RDT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00493922
First Posted: June 29, 2007
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ghana Health Services
Information provided by (Responsible Party):
Brian Greenwood, London School of Hygiene and Tropical Medicine
  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 Procedure: Rapid diagnostic test Procedure: Microscopy Procedure: Clinical diagnosis for malaria Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Individually Randomised Trial of Rapid Diagnostic Tests in Rural Ghana

Resource links provided by NLM:


Further study details as provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:

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 ]

Enrollment: 7263
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Microscopy for diagnosis of malaria
Procedure: Microscopy
Microscopy for diagnosis of malaria
Active Comparator: 3
Clinical diagnosis for malaria
Procedure: Clinical diagnosis for malaria
The use of Clinical diagnosis for the diagnosis of malaria
Experimental: 1
Rapid Diagnostic Test for Malaria
Procedure: Rapid diagnostic test
Introduction of rapid diagnostic test for malaria

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): NCT00493922


Locations
Ghana
Dangme West District
Dodowa, Greater Accra, Ghana
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Ghana Health Services
Investigators
Principal Investigator: Evelyn K Ansah, MD MPH PhD Ghana Health Services
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT00493922     History of Changes
Other Study ID Numbers: REG-8
First Submitted: June 28, 2007
First Posted: June 29, 2007
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by Brian Greenwood, London School of Hygiene and Tropical Medicine:
Malaria
Diagnosis
Rapid diagnostic tests
Microscopy
Clinical diagnosis
Africa

Additional relevant MeSH terms:
Malaria
Bacterial Infections
Protozoan Infections
Parasitic Diseases