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

Muhimbili University of Health and Allied Sciences (MUHAS)

Status and phase: Completed; Phase 4

Conditions: Instantaneous Clearance

Treatments: Drug: Artemether/lumefantrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01998295

2.0.2011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 6 to 120 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Artemether/lumefantrine

Active Comparator group

Description:

Artemether/lumefantrine tablets, 6 doses, for 3 days Dosage: 1. tablet for body weight between 5-14.9 Kilograms. 2. tablets for body weight between 15-24.9 Kilograms. 3. tablets for body weight between 25-34.9 Kilograms.

Treatment:

Drug: Artemether/lumefantrine