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

Plasmodium Falciparum Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843764
• Other study ID #: RDT-ClearTZ1
• Secondary ID: KI-MUHAS1
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: May 2, 2013
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Intervention

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

Locations

Country	Name	City	State
Tanzania	Mlandizi Health Centre and Fukayosi dispencary	Dar es Salaam	Kibaha and Bagamoyo district
Tanzania	Muhimbili University of Health Allied Science	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Anders Björkman	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance time with five diagnostic tests	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.	2009 June to 2012 May (up to day 42)	No
Primary	Detection of recurrent infection with HRP2 and LDH-based Rapid diagnostic tests during follow up	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.	2009 June to 2012 May (up to day 42)	No
Secondary	Efficiency of P.falciparum specific rapid diagnostic tests	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.	2009 June to 2012 May (up to day 42)	No