To assess the efficacy and tolerability of three antimalarial treatments in The Democratic Republic of Congo (DRC)

A randomised study to assess the efficacy and tolerability of three Artemisinin-based combination therapy (ACT) in The Democratic Republic of Congo (DRC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20984426

Enrollment

684

Registered

2011-10-06

Start date

2011-09-08

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

Malaria Infections and Infestations Plasmodium falciparum malaria

Interventions

This is a randomised, open study, comparing three ACTs, dihydroartemisinin-piperaquine (DHA-PQ), artemether?lumefantrine (ALN) and amodiaquine-artesunate coformulated (AQ-AS), for the treatment of sym

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Children aged 3 to 59 months 2. Weight = 5 kg [the minimum weight for treatment with artemether-lumefantrine (ALN)] 3. Mono-infection with P. falciparum 4. Parasitaemia of =2,000 and =200,000 asexual parasites per µL 5. Axillary temperature 37.5 °C or history of fever in the preceding 24 hrs 6. Ability to swallow oral medication 7. Haemoglobin =5.0 g/dL 8. Parents/guardians agree to hospitalize the child for the length of treatment (34 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42 9. Signed consent from guardian / parents

Exclusion criteria

Exclusion criteria: 1. Danger signs of severe malaria or signs of severe malaria (WHO 2000) 2. Children with severe malnutrition, marasmus or oedematous malnutrition (WHO 2006) 3. Febrile condition due to diseases other than malaria [e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal or hepatic diseases, human immunodeficiency virus (HIV) / acquired immune deficiency syndrome (AIDS)] 4. History of hypersensitivity reactions or contraindication to any medicine being tested 5. A clear history of adequate antimalarial treatment in the preceding 72 hours with drugs expected to be effective 6. Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocisti carini pneumonia in children born to HIV positive women

Design outcomes

Primary

Measure	Time frame
1. Clinical and parasitological cure by day 42 post-treatment 2. Treatment tolerability	—

Secondary

Measure	Time frame
1. The median parasite clearance time (PCT) 3. Fever clearance time (FCT)	—

Countries

Congo, Democratic Republic

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026