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

• Sponsor: Anders Björkman (Other)
• Overall Status: Completed
• CT.gov ID: NCT01843764
• Collaborator: Muhimbili University of Health and Allied Sciences (Other)
• Enrollment: 53
• Locations: 2
• Duration (Months): 36
• Patients Per Site: 26.5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Plasmodium Falciparum Malaria	Device: HRP2 and LDH based rapid diagnostic tests for P.falciparum

Study Design

• Study Type: Observational
• Actual Enrollment: 53 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Efficacy of Plasmodium Falciparum Specific Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Infections After Antimalarial Treatment
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
children with malaria Tanzanian children between 6-59 months with an uncomplicated P.falciparum monoinfection, followed after arthemeter-lumefantrine treatment according to national treatment guidelines	Device: HRP2 and LDH based rapid diagnostic tests for P.falciparum; Other Names: ParaHit (HRP2) CareStart (pLDH)

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 59 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mlandizi Health Centre and Fukayosi dispencary	Dar es Salaam	Kibaha and Bagamoyo district	Tanzania
2	Muhimbili University of Health Allied Science	Dar es Salaam		Tanzania	65001

Sponsors and Collaborators

• Anders Björkman
• Muhimbili University of Health and Allied Sciences

Investigators

• Study Director: Anders Björkman, Professor, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anders Björkman, Professor, Karolinska University Hospital
• ClinicalTrials.gov Identifier: NCT01843764
• Other Study ID Numbers: RDT-ClearTZ1; KI-MUHAS1
• First Posted: May 1, 2013
• Last Update Posted: May 3, 2013
• Last Verified: May 1, 2013

• Keywords provided by Anders Björkman, Professor, Karolinska University Hospital: RDT; malaria; treatment follow up; diagnosis
• Additional relevant MeSH terms: Malaria; Malaria, Falciparum

Study Results

No Results Posted as of May 3, 2013