Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Malaria Infections

Completed

• Conditions: Plasmodium Falciparum Malaria
• Interventions: Device: HRP2 and LDH based rapid diagnostic tests for P.falciparum

• Registration Number: NCT01843764
• Lead Sponsor: Anders Björkman

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2011-04
• Study Completion: 2012-06
• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-04-30
• Status Verified: 2013-05
• Study First Posted: 2013-05-01
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• children between 6-59 months
• fever (≤37.5 C) or history of fever during the preceding 24 hours
• confirmed P.falciparum monoinfection
• uncomplicated malaria
• parasite density between 2000-250.000/µL
• willing/able to comply with the 42 day follow up
• informed concent from patient/guardian

Exclusion Criteria

• children with history of antimalaria drug intake within the last two weeks
• symptoms / signs of severe disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children with malaria	HRP2 and LDH based rapid diagnostic tests for P.falciparum	Tanzanian children between 6-59 months with an uncomplicated P.falciparum monoinfection, followed after arthemeter-lumefantrine treatment according to national treatment guidelines

Primary Outcome Measures

Name	Time	Method
Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up	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.
Clearance time with five diagnostic tests	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.

Secondary Outcome Measures

Name	Time	Method
Efficiency of P.falciparum specific rapid diagnostic tests	2009 June to 2012 May (up to day 42)	Efficiency of two rapid diagnostic tests based on two different antigens for diagnosis and treatment follow up among children \<5 years in a moderately high endemic area was determined. Specificity and false positivity rate for HRP2 and LDH based rapid diagnostic tests are calculated against Giemsa stained microscopy and PCR.

Trial Locations

Locations (2)

Mlandizi Health Centre and Fukayosi dispencary; 🇹🇿 Dar es Salaam, Kibaha and Bagamoyo district, Tanzania

Muhimbili University of Health Allied Science; 🇹🇿 Dar es Salaam, Tanzania