A pilot study comparing the efficacy of artesunate alone and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in central Vietnam

A pilot study comparing the efficacy and tolerability of artesunate alone and artesunate plus azithromycin for the treatment of Plasmodium falciparum malaria in central Vietnam

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000546055

Enrollment

Registered

2010-07-07

Start date

2010-05-17

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

Artemisinin-based combination treatments (ACT) are now recommended as first-line treatment for Plasmodium falciparum malaria worldwide. Recent studies have shown reduce susceptibility of artesunate in western Cambodia and thus there is an urgent need to know whether artesunate resistance is present in neighbouring Southeast Asian countries such as Vietnam. In this study, we propose to assess whether reduce susceptibility exists at a commune in central Vietnam by giving patients a 7 day course of artesunate alone. At the same time, we will evaluate the efficacy of the ACT, artesunate plus azithromycin as this combination is meant to be safe in special risk groups such as young children and during pregnancy. However, before testing the artesunate plus azithromycin in special risk groups we need to know that the ACT is efficacious in the general population between 5 and 65 years.

Interventions

Malaria patients will be given either artesunate alone (4 mg/kg on the first day of treatment then 2 mg/kg daily for 6 days) or artesunate (4 mg/kg) plus azithromycin (20 mg/kg) daily for 3 days for the treatment of uncomplicated falciparum malaria. The mode of administration will be by the oral route.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 65 Years

Healthy volunteers

Inclusion criteria

(i) Patients with falciparum malaria with parasitaemia between 100 and 200,000 parasites/uL of blood (ii) Is willing to give small amounts of blood via finger prick and phlebotomy (iii) Written informed consent and agreed to treatment follow-up for a total of 28 days for artesunate alone and 42 days for artesunate plus azithromycin.

Exclusion criteria

(i) Severe/cerebral malaria or history of another serious medical disease (ii) Prior treatment with an artemisinin drug within the previous 7 days (iii) Pregnancy and lactating (iv) Inability to communicate well with the investigator (poor mental development or evidence of psychiatric disorder)

Outcome results