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chlorproguanil-dapsone-artesunate

Phase 3

Malaria, Falciparum | Small molecule | Infectious Disease |GSK plc|Last Updated: Dec 6, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment2,295

FDA Designations

No designations recorded

Clinical trial landscape

chlorproguanil-dapsone-artesunate · 3 trials · 2 indications

Phase 3 2Phase 2 1
NCT00344006Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated MalariaMalaria, Falciparum
COMPLETED1,395 Analytics
NCT00371735Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated MalariaMalaria, Falciparum
COMPLETED900 Analytics
PHASE3COMPLETED
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Malaria, Falciparum
NCT003440061,395
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PHASE3COMPLETED
Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria
Malaria, Falciparum
NCT00371735900
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Study Endpoints

Primary Endpoints

Parasitological cure rate, PCR corrected, at day 28 in the PP population The ITT population is a key supportive analysis.
Parasitological cure rate, PCR-corrected, at day 28, in the per-protocol population. Parasitological cure rate is defined as the clearance of the initial malaria infection by day 7 and remaining free of this infection to the day of assessment.
Treatment differences between 1,2, or 4mg/kg artesunate with a fixed dose of Chlorproguanil-dapsone (LAPDAP), as measured by determination of PC90 (time to achieve reduction of parasitaemia by 90% of baseline)

Secondary Endpoints

Parasitological cure rate, PCR-corrected, at day 14 and 42 ACPR, and ACPR PCR corrected at day 14, 28 and 42 Summary of asexual parasite densities on days 0, 1, 2, 3, 7, 14, 28 and 42 by treatment group.
The proportion of subjects with parasites remaining at 24 hours post-first dose by treatment group. Parasitological cure rate, PCR-corrected, at day 14, by treatment group.
The key secondary efficacy endpoint is parasite viability (the proportion of ring-form parasites developing to schizonts) determined from rich adult data and confirmed with more sparse child data
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -

Interventions

NameTypeDescription
chlorproguanil-dapsone-artesunateDRUG -
artemether-lumefantrineDRUG -
chlorproguanil-dapsoneDRUG -
Chlorproguanil-dapsone-artesunate (CDA)DRUG -
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Eligibility Criteria

Age Range12 Months to 14 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion criteria: * Acute, uncomplicated P.falciparum malaria, microscopically confirmed * Temperature at screening of 37.5oC or or more or confirmed history of fever within previous 24 hours * Weigh 7.5kg or over * Screening haemoglobin (Hb) of 7g/dl or over, or haematocrit of 25% or more(If Hb ...

Countries:Burkina FasoGhanaKenyaNigeriaTanzaniaMaliMalawiThe Gambia
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Frequently asked questions about chlorproguanil-dapsone-artesunate

What is Chlorproguanil-dapsone-artesunate used for?

Chlorproguanil-dapsone-artesunate is an investigational small molecule combination therapy being studied for the treatment of malaria, including uncomplicated falciparum malaria. It combines chlorproguanil, dapsone, and artesunate in a single regimen. The drug is developed by GSK plc and is currently in Phase 2 clinical development.

What does Chlorproguanil-dapsone-artesunate target?

Chlorproguanil-dapsone-artesunate is a combination of three antimalarial agents: chlorproguanil, dapsone, and artesunate. Each component acts on different targets within the malaria parasite to inhibit its growth and replication. The combination is designed to improve efficacy and reduce the risk of resistance compared to monotherapy.

Who makes Chlorproguanil-dapsone-artesunate?

Chlorproguanil-dapsone-artesunate is being developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for the treatment of malaria.

What phase is Chlorproguanil-dapsone-artesunate in?

Chlorproguanil-dapsone-artesunate is currently in Phase 2 clinical development. Although two Phase 3 trials have been completed, the overall development program is classified as Phase 2, indicating that the drug is still investigational and has not been approved by regulatory authorities. Further studies may be needed to establish its safety and efficacy.

What clinical trials is Chlorproguanil-dapsone-artesunate in?

Chlorproguanil-dapsone-artesunate has been evaluated in three completed clinical trials. NCT00344006 compared it to Coartem for uncomplicated malaria in 1,395 patients across five African countries. NCT00371735 compared it to chlorproguanil-dapsone in 900 patients. NCT00519467 assessed safety and efficacy of artesunate combined with LAPDAP in 120 adults. All trials are completed.

Is Chlorproguanil-dapsone-artesunate the same as LAPDAP?

Chlorproguanil-dapsone-artesunate is not the same as LAPDAP. LAPDAP refers to the combination of chlorproguanil and dapsone without artesunate. Chlorproguanil-dapsone-artesunate adds artesunate to the LAPDAP backbone. Clinical trials have compared the two regimens to evaluate the added benefit of artesunate in treating uncomplicated falciparum malaria.