A comparison of artemisinin combination treatment in the form of CoartemÂ® (artemether-lumefantrine) with sulfadoxine-pyrimethamine for treatment of uncomplicated malaria in Jhapa District, Nepal

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000551695

Enrollment

120

Registered

2005-09-29

Start date

2005-08-01

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

To assess whether the existing treatment for uncomplicated malaria in eastern parts of the Terai in Nepal (supfadoxine-pyrimethamine) is still effective and to determine whether artemether-lumefantrine is a more effective alternative is a significant treatment failreu rate for SP is present

Interventions

Artemether-lumefantrine or sulfadoxine pyrmethamine both given in recommended dose regimens (6 doses over 3 days for artemether-lumefantrine and a single dose for sulfadoxine pyrimethamine).

Study design

Allocation

Non-randomised trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to No maximum

Healthy volunteers

Inclusion criteria

i) Uncomplicated falciparum or mixed falciparum/vivax infection, ii) Asexual parasite density >500/ul whole blood, iii) No prior antimalarial therapy within the last 3 months, iv) Temperature > 37.5C axillary, v) Absence of sensitivity to SP or chloroquine, vi) Ability to attend follow-up visits.

Outcome results