None listed
Conditions
Brief summary
Febrile malaria patients aged above 6 months were recruited to evaluate the efficacy and safety of artesunate sulfadoxine/pyrimethamine (ASSP) for the treatment of uncomplicated P. falciparum infection and of chloroquine (CQ) for the treatment of uncomplicated P. vivax infection. Clinical and parasitological parameters were monitored for 28 days to determine the proportion of patients with treatment failure, prevalence of adverse events, and polymorphism of molecular markers for artemisinin (K13), piperaquine (pm2 amplification) and mefloquine (mdr-1 amplification) resistance.
Interventions
The study was a single-arm prospective trial to evaluate the efficacy and safety of artesunate + sulfadoxine/pyrimethamine (AS-SP) for the treatment of uncomplicated P. falciparum and chloroquine for the treatment of uncomplicated P. vivax. For treatment with artesunate + sulfadoxine/pyrimethamine, patients received 4mg/kg body weight artesunate once daily for three consecutive days plus a single dose of 25/1.25 mg/kg body weight sulfadoxine/pyrimethamine on the first day. For the P. vivax patie
The study was a single-arm prospective trial to evaluate the efficacy and safety of artesunate + sulfadoxine/pyrimethamine (AS-SP) for the treatment of uncomplicated P. falciparum and chloroquine for the treatment of uncomplicated P. vivax. For treatment with artesunate + sulfadoxine/pyrimethamine, patients received 4mg/kg body weight artesunate once daily for three consecutive days plus a single dose of 25/1.25 mg/kg body weight sulfadoxine/pyrimethamine on the first day. For the P. vivax patients, chloroquine 25 mg/kg body weight for 3 days (10 mg/kg on day 1, 10 mg/kg on day 2, and 5 mg/kg on day 3) was given. Artesunate+sulfadoxine/pyrimethamine tablets (100 mg artesunate tablet and one tablet 25 mg/500 mg SP) manufactured by Guilin Pharmaceutical CO., Ltd. China, and chloroquine tablet (150 mg base) was manufactured by Medopharma, India, and was obtained from the World Health Organization (Headquarter). All treatments were administered orally under the direct supervision of medical personnel. All study patients were followed up for 28 days.
Sponsors
Ministry of Public Health Afghanistan
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. age above 6 months, excluding female minors aged 12-15 years and unmarried women for the falciparum study 2. mono-infection with P. falciparum or P. vivax detected by microscopy; 3. parasitaemia of 500-200,000 per microL asexual forms 4. presence of axillary temperature greater or equal to 37.5 degrees centigrade 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 the patient, or from a parent or guardian in the case of children under 16 years of age 8. Informed assent from any minor participant in the P. falciparum study aged from 12 to 15 years 9. Consent for pregnancy testing from married female of child-bearing age for the P. falciparum sub-study
Exclusion criteria
1. presence of general danger signs in children aged under 5 years and adults or signs of severe falciparum malaria according to the definitions of WHO 2. Weight under 5 kg 3. mono-infection of P. malariae or mixed with another Plasmodium species detected by microscopy 4. Presence of severe malnutrition (defined as a child who has a mid-upper arm circumference below 110 mm) 5. 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) 6. regular medication, which may interfere with antimalarial pharmacokinetics; 7. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); 8. a positive pregnancy test or breastfeeding for potential participants in the P. falciparum group 9. unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active for the falciparum group
Outcome results
None listed