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Clinical investigation of in-vivo susceptibility of Plasmodium falciparum to artesunate in Western Cambodia (study 2)

Clinical investigation of in-vivo susceptibility of Plasmodium falciparum to artesunate in Western Cambodia (study 2)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15351875
Enrollment
160
Registered
2008-05-16
Start date
2008-04-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute falciparum malaria Infections and Infestations Plasmodium falciparum malaria

Interventions

Current interventions as of 22/02/2010: Arm 1 (N = 40): receive artesunate alone at a dose of 6 mg/kg/day for seven days Arm 2 (N = 40): receive artesunate alone at a dose of 6 mg/kg/day in two divide

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children greater than 6 years old and adults (either sex) presenting with acute falciparum malaria will be eligible for this study provided that: 1. They or their parents/guardians give fully informed consent 2. They have not received antimalarial drugs in the previous 48 hours 3. Plasmodium falciparum parasitaemia exceeds 10,000 /uL 4. They agree to seven days of hospitalisation

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Microscopy indicates a mixed infection 3. History of allergy to artesunate or mefloquine

Design outcomes

Primary

MeasureTime frame
Parasite clearance times in relation to artesunate/dihydroartemisinin (DHA) plasma concentration (PK/PD) (time point: 63 days).

Secondary

MeasureTime frame
1. Cure rates (time point: 63 days) 2. In vitro sensitivity of P. falciparum to artesunate measured prior to treatment (time point not applicable) 3. Molecular markers of drug resistance measured prior to treatment (time point not applicable)

Countries

Cambodia, Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 25, 2026