Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in South Sudan

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12612000938808
• Date of registration: 04/09/2012
• Prospective Registration: No
• Primary sponsor: Ministry of Health of the Republic of South Sudan
• Public title: Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in South Sudan
• Scientific title: Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites in South Sudan
• Date of first enrolment: 01/06/2012
• Target sample size: 540
• Recruitment status: Withdrawn
• URL: https://anzctr.org.au/ACTRN12612000938808.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Sudan

Contacts

• Name: Dr Dr. Margaret Betty Eyobo

• Name: Dr Dr. Margaret Betty Eyobo

Key inclusion & exclusion criteria

Inclusion criteria: 1. age between 6 to 59 months;
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 the patient or 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 (Appendix 1) in children (aged 6- 59 months);
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, has symmetrical oedema involving at least the feet or has 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).

Age minimum: 6 Months
Age maximum: 59 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Malaria;
Malaria

Infection - Studies of infection and infectious agents

Intervention(s)

To assess the efficacy and safety of artesunate/amodiaquine (standard dose of 30mg/kg of amodiaquine (10mg/kg x 3 times per day for 3 days) and 12mg/kg of artesunate (4mg/kg x 3 times per day for 3 days) for the treatment of uncomplicated P. falciparum infection. The treatment will be taken orally. Eligibile subjects will be treated for three days and followed up for 28 days.

Primary Outcome(s)

Percent of treatment failures (early treatment failure + late clinical failure + late parasitological failure)

Enrolled patients will be assessed for parasitological (using microscopy), clinical responses during the 28 days follow-up and treatment outcomes will be classified according to the latest WHO protocol.[At day 28 following initiation of treatment]

Secondary Outcome(s)

Percent of adverse event will be documented. Parents or guardians of all enrolled patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. When clinically indicated, patients will be evaluated and treated appropriately. All adverse events will be recorded on the case report form.

Possible medicine related adverse effects include dizziness, itching, vomiting, abdominal pain, flatulence, headache, bodyache, diarrhoea, tinnitus and increased hair loss, macular rash, reduction in neutrophil counts and convulsions. However, it is likely that many of these effects are disease-related rather than medicine-induced.

A patient can be discontinued from the study if the principal investigator decides so due to an adverse event of adequate nature or intensity. In this case, information on the adverse event and symptomatic treatment given must be recorded on a case report form. If the adverse event is serious, the principal investigator must notify the sponsor or its designee immediately and follow the reporting procedure as indicated in the Protocol.

The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy.

Adverse events requiring treatment can be treated according to local practice. If there is a clinical indication for any additional medication during the course of the study, including medication given to treat an adverse event related to the study medicine, the name of the medicine, the dosage and the date and time of administration must be recorded on the case report form.[At day 28 following initiation of treatment.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

The Global Fund to fight AIDS, Tuberculosis and Malaria

Secondary Sponsor(s)

World Health Organization

Ethics review

Status: Approved
Approval date:
Contact:

Ministry of Health, Republic of South Sudan