Efficacy and safety of artesunate+sulfadoxine/ pyrimethamine and artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sites of Somalia

Not Applicable

Recruiting

• Conditions: Malaria; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12612001128886
• Lead Sponsor: Ministry of Health and Human Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

1. age between 6 months and 60 years with the exception of 12-18 years old female minors and unmarried females above 18 years;
2. mono-infection with P. falciparum detected by microscopy;
3. parasitaemia of 500 - 200000/microlitre asexual forms;
4. presence of axillary temperature equal to or greater than 37.5 degrees C or history of fever during the past 24 hours;
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 in the case 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 whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference less than 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); and
7. a positive pregnancy test or breastfeeding;
8. Unable to or unwilling to take a pregnancy test or contraceptives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of treatment failure (early treatment failure, late clinical failure, late parasitological failure).<br><br>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 treatment]

Secondary Outcome Measures

Name	Time	Method
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.<br><br>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.[at day 28 following treatment]