Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Brazzaville and Owando - Republic of the Congo

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000940875

Acronym

Nil

Enrollment

352

Registered

2012-09-04

Start date

2012-05-01

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Efficacy and safety of artesunate/amodiaquine and artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in two sites in the Congo

Interventions

To assess the efficacy and safety of artesunate/amodiaquine (4 mg/kg of artesunate, 10 mg/kg of amodiaquine, 1/day for 3 days) (oral administration) for the treatment of uncomplicated P. falciparum infections in two sites in the Republic of Congo

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

6 Months to 10 Years

Healthy volunteers

Inclusion criteria

1. age between 6 months and 10 yeasr; 2. mono-infection with P. falciparum detected by microscopy; 3. parasitaemia of 1000-200,000/microlitre asexual forms; 4. presence of axillary (greater or equal to) 37.5 degrees C or history of fever during the past 24 h; 5. ability to swallow oral medication; 6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and 7. informed consent from a parent or guardian of children.

Exclusion criteria

1. presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO; 2. mixed or mono-infection with another Plasmodium species detected by microscopy; 3. presence of severe malnutrition (defined as a child whose growth standard is below –3 (z-score), having a symmetrical oedema involving at least the feet or having a mid-upper arm circumference < 110 mm); 4. presence of febrile conditions 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 and hepatic diseases, HIV/AIDS); 5. regular medication, which may interfere with antimalarial pharmacokinetics; 6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).

Outcome results