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Completed

NCT Number: NCT01998295

Parasite Clearance Time and Time to Recurrent Infection Following Treatment With Artemether/Lumefantrine

Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is not known whether the problem exist in Tanzania. This study assessed parasite clearance time and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among children with uncomplicated malaria.

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Key information

Conditions

Instantaneous Clearance

Age range

6 month–120 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Muhimbili University of Health and Allied Sciences

Dar es Salaam, 65001, Tanzania

About this study

Artemether/Lumefantrine (AL) has been in wide scale use in Tanzania since 2007 as first line treatment for uncomplicated falciparum malaria. Nonetheless, reports of confirmed resistance against Artemisinin derivatives expressed phenotypically as prolonged parasite clearance have emerged from South-East Asia (SEA), signifying reduced parasites susceptibility to the otherwise rapidly acting artemisinins. Prolonged clearance is associated with an increase in day 28 treatment failure, gametocytes carriage and transmission of resistance. Nonetheless, no detailed study has been done in East Africa to assess parasite clearance time following treatment with Artemisinin based combination therapies (ACTs).

In order to evaluate time to parasite clearance following treatment with AL, we conducted a detailed clinical trial with twenty blood sampling time points prior, during and after treatment. Detailed sampling allowed us to assess parasite clearance, and selection of Plasmodium falciparum multidrug resistance (Pfmdr) 1 N86Y and Plasmodium falciparum chloroquine resistance transporter (Pfcrt) K76T genes between different time points and its association with parasite clearance and recurrence. Furthermore, as a sensitive tool and an ideal early warning system, nested polymerase chain reaction (PCR) was used to assess parasite clearance and compare it with microscopic findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6-120 months
  • Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL
  • No general danger signs or severe malaria present
  • Hemoglobin ≥5 g/dL
  • History of fever within 24 hours or axillary temperature ≥ 37.5 degree Celsius
  • No other cause of fever is detectable
  • No severe malnutrition
  • Guardian/patient has consented

Exclusion criteria

  • general danger signs or signs of severe falciparum malaria
  • severe malnutrition
  • febrile condition due to diseases other than malaria
  • regular medication which might interfere with antimalarial pharmacokinetics
  • contraindications to any medicine being used

Treatment and study plan

artemether/lumefantrine

Drug

Medication was given at 0, 8, 24, 36, 48 and 60 hours. Food was given to all patients prior to medication to ensure proper absorption of the drug.

Other names: Coartem

Primary outcomes

  1. Time to parasite clearance

    Time frame: 72 hours

    Time to parasite clearance was assessed by taking blood samples and examining it by light microscopy prior (0 hour) and during treatment at 4, 8, 12 hours and then 6 hourly until two consecutive negative blood slides.

Secondary outcomes

  1. Time to recurrent infection

    Time frame: 42 days

    Time taken for parasites to reappear in the peripheral blood of the participant after initial treatment was assessed during the 42 days of follow up from blood samples taken on days 14, 21, 28 and 42.

Other outcomes

  1. Time to parasite clearance

    Time frame: 7 days

    Blood samples collect on filter papers prior (0 Hour), during and after medication at 4, 8, 12 and after every 6 hours until 72 hours and on day 7 were analyzed by PCR to assess parasite clearance. Parasite positivity after day 7 was considered as recurrent infection.

  2. Time to alleles clearance

    Time frame: 168 hours

    Time to clearance of parasites carrying Pfmdr 1 N86Y and Pfcrt K76T alleles was assessed by molecular genotyping using blood samples collected during the early phase of treatment.

Sponsors and collaborators

Lead sponsor

Muhimbili University of Health and Allied Sciences

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Parasite Clearance Time and Time to Recurrent Infection Following Treatment With Artemether/Lumefantrine Among Children With Uncomplicated P. Falciparum Malaria Five Years After Wide Scale Use of the Drug in Tanzania

Acronym: PCT

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 28, 2013
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.