Efficacy and safety of artesunate in treatment of malaria caused by Plasmodium falciparum parasite in Guyana

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616000526471
• Date of registration: 22/04/2016
• Prospective Registration: No
• Primary sponsor: Regional Office for the Americas of the World Health Organization
• Public title: Efficacy and safety of artesunate in treatment of malaria caused by Plasmodium falciparum parasite in Guyana
• Scientific title: Efficacy and safety of artesunate in treatment of malaria caused by Plasmodium falciparum parasite in Guyana
• Date of first enrolment: 12/06/2014
• Target sample size: 50
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616000526471.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Guyana

Contacts

• Name: Dr Reyaud Rahman

• Name: Dr Reyaud Rahman

Key inclusion & exclusion criteria

Inclusion criteria: 1. age greater or equal to 2 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 1000–100,000/microliter asexual forms;
4. presence of axillary temperature 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;
7. informed consent from patients or parent or guardian of children.
Exclusion criteria: 1. presence of general danger signs in children aged under 5 years 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 aged 6-60 months has a mid-upper arm circumference belo 115 mm)
4. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea 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);
7. a positive pregnancy test or breastfeeding (include this criterion only if adults are included);
8. unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age);
9. previous antimalarial drug intake in the past 48 hours;
10. Patients presenting with splenectomy.



Age minimum: 2 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Studies of infection and infectious agents

Malaria;
Malaria

Intervention(s)

To assess the efficacy and safety of artesunate (4 mg/kg body weight) once daily for 7 consecutive days) for the treatment of uncomplicated P. falciparum infection.. The treatment was taken orally under direct supervision by the health worker. The drug was tested in one site. Eligibile subjects were treated for 7 days days and followed up for 28 days.

Primary Outcome(s)

Day 3 positivity rate and parasite clearance time with blood sampling for parasite counts 8 hourly until patient became negative[Day 3 positivity rate: at day day 3
Parasite clearance time: 8 hourly on days 1, 2, 3 until the patient became negative.]

Percent of treatment failures (early treatment failure + late clinical failure +late parasitological failure) and adequate clinical and parasitological responses. This was composite primary outcome.

Enrolled patients were assessed for parasitological (using microscopy) and clinical (axillary temperature equal or more 37.5 centigrade) responses during the 28 days follow-up. Standard physical examination was performed and axillary temperature was measured at baseline, during the treatment and post-treatment over 28 days. Thick and thin blood films were collected and examined at baseline, during the treatment and post-treatment over 28 days.
Treatment outcomes was classified according to the latest WHO protocol (WHO 2009:.World Health Organization. Methods for surveillance of antimalarial drug efficacy).[At days 1, 2, 3, 7, 14, 21 and 28 following initiation of artesunate.]

Secondary Outcome(s)

Percent of adverse event was documented.
The known adverse events of artesunate are abdominal pain, diarrhoea, dizziness, nausea, vomiting.

Parents or guardians of all enrolled patients was asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients was evaluated and treated appropriately. All adverse events was recorded on the case report form.[At day 28 following inititation of artesunate]

Prevalence of artemisinin resistance molecular markers (K13).

Parasite DNA extracted from the dried blood spots was analyzed by PCR and sequencing for the presence of K13 (molecular marker for artemisinin resistance.[At Day 0 (prior initiation of treatment)]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Ministry of Health

Ethics review

Status: Approved
Approval date:
Contact:

Institutional Review Board, Ministry of Health