A phase III, randomised, non-inferiority trial, to assess the efficacy and safety of dihydroartemisinin and piperaquine (DHA + PPQ, Artekin®) in comparison with artesunate and mefloquine (AS + MQ) in patients affected by acute, uncomplicated Plasmodium falciparum malaria

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81306618

Enrollment

1050

Registered

2005-05-05

Start date

2000-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Malaria Infections and Infestations Malaria

Interventions

Randomisation will stratify infants, children and adults by age. Patients randomised to: 1. Tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine for adult patients or containing 20

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females aged between three months and 65 years inclusive 2. Body weight at least 5 kg 3. Microscopically confirmed, monoinfection of Plasmodium falciparum or mixed infection 4. History of fever or presence of fever (tympanic temperature at more than or equal to 37.5°C) 5. Written informed consent 6. 1050 patients (700 DHA + PPQ; 350 AS + MQ)

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
The Day 63, PCR corrected cure rates of artekin and AS+MQ	—

Secondary

Measure	Time frame
1. The comparison of the uncorrected Day 63 cure rates of both drugs (also known as adequate clinical and parasitological response [ACPR]) 2. The comparison of the amount of overall treatment failure 3. The comparison of the safety profiles of the two treatments 4. Proportion of patients with treatment failure (TF) 5. Proportion of aparasitaemic patients 6. Proportion of afebrile patients 7. Gametocytes carriage 8. Fractional change in haemoglobin/haematocrit	—

Measure

Time frame

1. The comparison of the uncorrected Day 63 cure rates of both drugs (also known as adequate clinical and parasitological response [ACPR]) 2. The comparison of the amount of overall treatment failure 3. The comparison of the safety profiles of the two treatments 4. Proportion of patients with treatment failure (TF) 5. Proportion of aparasitaemic patients 6. Proportion of afebrile patients 7. Gametocytes carriage 8. Fractional change in haemoglobin/haematocrit

—

Countries

India, Laos, Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026