None listed
Conditions
Brief summary
Title: Efficacy and safety of artesunate+sulfadoxine/pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria in four sites of Pakistan. Background: Therapeutic efficacy studies will be done in Somalia to assess the efficacy and safety of artesunate+ sulfadoxine/pyrimethamine for the treatment of uncomplicated falciparum malaria. The participants will be febrile people aged between 6 months and 60 years except female minors aged 12-17 and umarreied women aged 18 years and above. Patients will be treated with tesunate+sulfadoxine/pyrimethamine once a day over 3 consecutive days. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. The results of this study will be used to assist the Ministry of Health of Pakistan in assessing the current national treatment guidelines for uncomplicated P. falciparum.
Interventions
One arm propective evaluation with artesunate+sulfadoxine+ pyrimethamine for the treatment of uncomplicated Plasmodium falciparum malaria. Eligible subjects will be treated with artesunate+sulfadoxine+pyrimethamine. All patients will be followed up for 28 days.
Dose regimen:
artesunate+sulfadoxine/pyrimethamine tablets: artesunate 4 mg/kg body weight per day for 3 days plus a single dose of sulfadoxine 25/1.25 pyrimethamine mg/kg body weight.
All treatment will be orally taken tablets.
Sponsors
Liaqat University of Medicine and Health Sciences
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 60 Years
Healthy volunteers
No
Inclusion criteria
*age between 6 months and 60 years with the exception of 12-17 years old female minors and unmarried females aged 18 years and above; *mono-infection with P. falciparum detected by microscopy; *parasitaemia of 1000 – 250000 / micro liter asexual forms for sites in Sindh, Baluchistan and FATA and parasitaemia of 250 – 250000 / microliterl asexual forms for the site in Punjab; *presence of axillary temperature greater or equal to 37.5 degrees centigrade or history of fever during the past 24 h; *ability to swallow oral medication; *ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and *informed consent from the patient or from a parent or guardian in the case of children.
Exclusion criteria
*presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization (WHO); *mixed or mono-infection with another Plasmodium species detected by microscopy; *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); *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, Human Immuno Deficiency Virus /Auto Immune Deficiency Syndrome (HIV/AIDS); *regular medication, which may interfere with antimalarial pharmacokinetics; *history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); and *a positive pregnancy test or breastfeeding; *Unable to or unwilling to take a pregnancy test or contraceptives.
Outcome results
None listed