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Open randomized study for the evaluation of activities of AS/AQ (co-packaged and co-formulated) versus AL on asexual & sexual paraistes in children

An open label, randomized trial of the therapeutic efficacy, safety and tolerance of co-packaged amodiaquin plus artesunate versus co-formulated artesunate plus amodiaquine versus artemether lumefatrine for the treatment of uncomplicated Plasmodium falciparum malaria in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201508001188143
Enrollment
Unknown
Registered
2015-07-03
Start date
2009-08-01
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Malaria Paediatrics

Interventions

artemisinin plus amodiaquine (co-formulated)

Sponsors

Swiss Pharma Nigeria Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: boby weight at least 5 kg History of fever microscopically confirmed pure Plasmodium falciparum infection >/= 2000/uL Presence or history of fever (temp. >37.4) written informed consent

Exclusion criteria

Exclusion criteria: severe malaria History of alergy to study drugs Presence of concomitant illness Signs of severe malnutrition Patient with history of hepatic, cardiac or renal disease.

Design outcomes

Primary

MeasureTime frame
28-42 days PCR-corrected cure rates

Secondary

MeasureTime frame
Proportion of patients with parasitaemia or fever;Prevalence and intesities of gametocytaemia

Countries

Nigeria

Contacts

Public ContactAkintunde Sowunmi

Professor

akinsowunmi@hotmail.com08052157893

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026