Monitoring and evaluation of efficacy and safety of Artesunate-Amodiaquine (ASAQ) in Ta Sanh Health Centre (Battambong) and Kvav Health Centre (Siem Reap) with a single 15-mg adult dose of Primaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Cambodia

Clinical and parasitological efficacy of artesunate-amodiaquine over 28 days in the treatment of uncomplicated falciparum malaria in Cambodia

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001628134

Enrollment

Registered

2019-11-25

Start date

2016-09-25

Completion date

2017-02-22

Last updated

2019-12-10

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

Conditions

None listed

Brief summary

This therapeutic efficacy study was to assess the efficacy of ASAQ for the treatment of P. malaria over 28 days. The result was useful for the policymakers to modify the current national treatment guideline for P. malaria infection in Cambodia

Interventions

It is a single-arm open-label study to evaluate the efficacy and safety of Artesunate-Amodiaquine (ASAQ) for the treatment of Plasmodium falciparum malaria. Eligible patients were treated with a daily dose of 1 tablet containing 135mg AQ and 50mg AS for the patients with 8-17 kg body weight over 3 days, 1 tablet containing 270mg AQ and 100mg AS for the patients with 17-35 kg body weight and 2 tablets for the patients above 35 kg body weight over 3 days. A single oral dose of 15-mg adult dose of Primaquine was given to the patient on the first day of treatment. The blood slide was daily examined until the patients it was negative on 2 consecutive days. The patients took each dose of the drug in front of the health staff, and they stayed at the study site for the first 3 or 4 days, and they returned to the study site weekly over 28 days.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 60 Years

Healthy volunteers

Inclusion criteria

- Patients with the bodyweight of 8 kg or above - P. falciparum infection - Ability to swallow the drug - Ability and willingness to comply with the study protocol

Exclusion criteria

- Pregnancy or lactation - Severe malaria - Mixed malaria infection

Outcome results