Combination Antimalarials in Uncomplicated Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00203801
• Date of registration: 29/08/2005
• Prospective Registration: No
• Primary sponsor: University of Cape Town
• Public title: Combination Antimalarials in Uncomplicated Malaria
• Scientific title: Open Label Study to Evaluate Combination Anti-malarial Therapy,in Terms of Efficacy, Prevalence of Gametocyte Carriage and Molecular Markers Associated With Sulfadoxine Pyrimethamine Resistance in Uncomplicated Plasmodium Falciparum
• Date of first enrolment: January 2002
• Target sample size: 700
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00203801
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Mozambique, South Africa, Swaziland

Contacts

• Name: Karen Barnes, MBChB
• Affiliation: University of Cape Town

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, older than 12 months.

- Weight > 10 kg.

- Diagnoses of uncomplicated acute P. falciparum malaria parasitaemia of up to 250 000
asexual parasite/mcl blood with axillary temperature of greater than and equal to 37.5
or history of fever

- Documented informed consent

- Lives close enough to the health centre for reliable follow up

Exclusion Criteria:

- Has received anti-malarial treatment in the past 7 days.

- Severely ill (based on WHO Criteria for severe malaria ) or if patient is considered,
in the opinion of the investigator or designee, to have moderately severe malaria
(e.g. prostrate, repeated vomiting, dehydrated).

- Has received cotrimoxazole or chloramphenicol in the past 7 days.

- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency (not a
contra-indication for artemether-lumefantrine).

- Is pregnant or breastfeeding.

- Has a history of allergy to any of the study drugs (including other sulphonamides e.g.
cotrimoxazole, other artemisinin derivatives e.g. artemether-lumefantrine).



Age minimum: 12 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: Artemether-lumefantrine

Drug: Artesunate plus sulfadoxine-pyrimethamine

Drug: Sulfadoxine-pyrimethamine

Primary Outcome(s)

Adequate Clinical and Parasitological Response (ACPR), Early Treatment Failure (ETF), Late Treatment Failure (LTF), defined as Late Clinical Failure (LCF) and Late Parasitological Failure (LPF);

Fever clearance time.

Therapeutic efficacy defined as:

Sensitive or parasitological failure (RI, early and late, RII, RIII)

Parasitological failures will be classified as recrudescence or re-infection (or indeterminate) using glutamate-rich protein (GLURP) and merozoite surface protein (MSP) I & II markers;

Parasite clearance time;

Secondary Outcome(s)

Association between study treatment and gametocyte carriage

Tolerability by describing adverse events and changes in haematological parameters

Capacity by describing the training and development of study teams and their subsequent skills attained

Correlation of frequency of dihydropteroate synthase (DHFR) and dihydrofolate reductase (DHPS) mutations with parasitological outcome

Pharmacokinetics by measurement of whole blood levels of Sulfadoxine and Pyrimethamine, and lumefantrine should a reliable assay become available

Secondary ID(s)

SEACAT 01 Mono (Am 1,2,3,5,6)

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical Research Council, South Africa

Global Fund

World Health Organization