NCT01843764

Efficacy of Plasmodium Falciparum Specific Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Infections After Antimalarial Treatment

Completed Last updated 2 May 2013

What this trial tests

trial testing HRP2 and LDH based rapid diagnostic tests for P.falciparum in Plasmodium Falciparum Malaria in 53 participants. Completed in 1 June 2012.

Timeline

1 June 2009

Primary endpoint
1 April 2011

1 June 2012

Quick facts

Lead sponsor	Anders Björkman
Status	Completed
Study type	OBSERVATIONAL
Enrollment	53
Start date	1 June 2009
Primary completion	1 April 2011
Estimated completion	1 June 2012
Sites	2 locations across Tanzania

Drugs / interventions tested

• HRP2 and LDH based rapid diagnostic tests for P.falciparum

Conditions studied

• Plasmodium Falciparum Malaria — all drugs for Plasmodium Falciparum Malaria →

Sponsor

Anders Björkman — full company profile →

Who can join

Adults 6 Months to 59 Months, any sex, with Plasmodium Falciparum Malaria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Clearance time with five diagnostic tests
  Time frame: 2009 June to 2012 May (up to day 42)
  Children were followed up on 9 occasions until day 42. Mean and median time until clearance after initiation of arthemeter-lumefantrine treatment was measured for HRP2 based Rapid diagnostic tests, LDH-based Rapid diagnostic tests, Giemsa and Acridine Orange stained microscopy and real-time PCR.
• Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up
  Time frame: 2009 June to 2012 May (up to day 42)
  Ability to detect recurrent malaria infection with the HRP2 and LDH-Rapid diagnostic tests during the 42 days of follow up was studied through comparing them with three other diagnostic tests.

Sponsor's own description

The aim of the study was to follow clearance of malaria infections and detection of new malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children during 42 days.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Usefulness of Plasmodium falciparum-specific rapid diagnostic tests for assessment of parasite clearance and detection of recurrent infections after artemisinin-based combination therapy.
   Aydin-Schmidt B, Mubi M, Morris U, Petzold M, et al · · 2013 · cited 41× · PMID 24079306 · DOI 10.1186/1475-2875-12-349