Rapid Diagnostic Tests (RDTs) for Malaria in Kampala, Uganda

NCT00327964 | Completed

• 1 other identifier: NIH/DMID 05-0110
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria remains a disease that causes much death and sickness, especially in sub-Saharan Africa. An accurate, simple, and inexpensive method of diagnosing malaria is urgently needed. The purpose of this study is to evaluate a different diagnostic method compared to those most frequently used. The study may also identify the factors causing false positive and false negative results using the alternative method. Participants will be 600 Ugandan children aged 1-10 years who are enrolled in protocol 04-068. Those who develop a fever over the 12 month duration of the study will be tested for malaria by both the standard and the new methods. These tests will require a few drops of blood to be collected by finger prick. Subjects will be treated on the basis of standard diagnostic testing (i.e. expert microscopy).

Conditions

Febrile Illness; Malaria

Keywords

malaria; fever; Uganda; children; rapid diagnostic tests; RDTs; Africa

Outcome Measures

Primary Outcomes (1)

• RDT accuracy

Study Arms (1)

study population

601 children enrolled in an on-going longitudinal antimalarial treatment efficacy trial in Kampala, Uganda.

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

601 children enrolled in a longitudinal antimalarial treatment efficacy trial in Kampala, Uganda.

You may qualify if:

• Ages 1-10 (at time of original enrollment)
• Parents' or guardians' agreement to bring the child to the study clinic for any fevers or other illnesses
• Agreement to avoid medications administered outside the study
• Intention to remain in Kampala for the full study period
• Native Ugandan

You may not qualify if:

• Presence of any known serious chronic disease (e.g. AIDS, sickle cell disease, malignancy)
• Serious side effects to study medications used in cohort clinical trial of antimalarial drug efficacy

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Mulago Hospital

Kampala, Uganda

Location

Related Publications (1)

• Hopkins H, Kambale W, Kamya MR, Staedke SG, Dorsey G, Rosenthal PJ. Comparison of HRP2- and pLDH-based rapid diagnostic tests for malaria with longitudinal follow-up in Kampala, Uganda. Am J Trop Med Hyg. 2007 Jun;76(6):1092-7.

  PMID: 17556616 RESULT

Related Links

• research collaboration website

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots on filter paper

MeSH Terms

Conditions

Malaria; Fever

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Heidi Hopkins, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2006
• First Posted: May 19, 2006
• Study Start: October 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

UG (1)