Time to Become Negative of Three Rapid Diagnostic Tests for Malaria

NCT01325974 | Completed

• 1 other identifier: Epicentre/Mba/2011/TTBN-RDTmal
• Study Type: observational
• Target: 424
• Locations: 1 country
• Sites: 2

Brief Summary

Background: Antigen-detecting rapid diagnostic tests (RDTs) for malaria provide the possibility of a parasite-based diagnosis in areas where good quality microscopy can not be achieved. P. falciparum tests targeting the histidine-rich protein (HRP2) antigen are generally more sensitive than tests targeting the Plasmodium lactate dehydrogenase (pLDH) antigen. However, as the HRP2 antigen is eliminated from the bloodstream more slowly than the pLDH antigen, HRP2-based tests can give a positive result two weeks or more after the patient has taken an effective treatment, while pLDH tests generally turn negative a few days after. The use of an RDT positive result in a routine patient care is therefore challenged by the interpretation of whether the result is due to a lasting effect of the already treated infection or to a new infection. The interpretation might also be affected by the level of malaria transmission in the area. Objective: The objective of this study is to estimate the proportion of positive tests in patients successfully treated for malaria (smear negative) at different time points in time after treatment, for three rapid diagnostic tests: SD Bioline Malaria Antigen P.f. (catalogue number: 05FK50-02-4), CareStart Malaria HRP2 (Pf) (catalogue number: G0141) and CareStart Malaria pLDH (PAN) (catalogue number: G0111). The study will be carried out in two settings with known low and high malaria transmission levels in order to provide guidance of interpretation of a RDT positive result depending on the intensity of malaria transmission. Secondary objectives will be to measure the sensitivity and specificity of the malaria rapid tests compared to smear microscopy, to estimate the median time to become negative for each of the tests and to estimate the proportion of positive tests and the median time to become negative according to the initial parasitaemia and the presence of gametocytes.

Conditions

Malaria, Falciparum

Keywords

Malaria; Plasmodium falciparum; Diagnosis; Rapid diagnostic test; malaria transmission

Outcome Measures

Primary Outcomes (1)

• To estimate the proportion of positive tests in patients successfully treated for malaria (smear negative) at different time points after treatment, for three rapid diagnostic tests: two HRP2 test and one pLDH test.

  day 2, 3, 5, 7, 14, 21, 28, 35 and 42 after the start of antimalarial treatment intake

Secondary Outcomes (3)

• To measure the sensitivity and specificity of the malaria rapid tests compared to smear microscopy.

  The day of patient's enrollment only (day 0)

• To estimate the median time to become negative for each of the rapid diagnostic test.

  day 2, 3, 5, 7, 14, 21, 28, 35 and 42 after the start of antimalarial treatment intake

• To estimate the proportion of positive tests among smear negative results and the median time to become negative according to the initial parasitaemia and the presence of gametocytes.

  day 2, 3, 5, 7, 14, 21, 28, 35 and 42 after the start of antimalarial treatment intake

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be patients under 5 years of age who attend the consultation service of one health centre of Mbarara municipality (low transmission setting) and one health centre in Kazo sub-county (high transmission setting).

You may qualify if:

• Age under 5 years
• Clinical malaria defined as fever (axillary temperature ≥ 37.5°C) or history of fever in the previous 48 hours
• Weight ≥ 5 kg
• Informed consent given by the parent or a tutor
• High probability of coming to all follow-up visits

You may not qualify if:

• General signs of danger or of severe malaria according to the WHO criteria
• Treatment course of antimalarials in the previous 2 weeks

Sponsors & Collaborators

• Epicentre: lead
• Medecins Sans Frontieres, Netherlands: collaborator

Study Sites (2)

Kazo level 4 health centre

Kazo, Greater Mbarara District, Uganda

Location

Mbarara Municipality level 2 health centre

Mbarara, Greater Mbarara District, Uganda

Location

Related Publications (1)

• Grandesso F, Nabasumba C, Nyehangane D, Page AL, Bastard M, De Smet M, Boum Y, Etard JF. Performance and time to become negative after treatment of three malaria rapid diagnostic tests in low and high malaria transmission settings. Malar J. 2016 Oct 4;15(1):496. doi: 10.1186/s12936-016-1529-6.

  PMID: 27716244 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood smears for microcopy

MeSH Terms

Conditions

Malaria, Falciparum; Malaria; Disease

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Grandesso, MSc

  Epicentre

  PRINCIPAL INVESTIGATOR

• Carolyn Nabasumba, MD

  Epicentre

  STUDY CHAIR

• Yap Boom, MSc, PhD

  Epicentre

  STUDY CHAIR

• Anne-Laure Page, PhD

  Epicentre

  STUDY CHAIR

• Mathieu Bastard, MSc

  Epicentre

  STUDY CHAIR

• Jean-François Etard, MD, PhD

  Epicentre

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: March 30, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

UG (2)