Clinical Malaria
Conditions
Keywords
malaria, treatment, cotrifazid, clinical trial, efficacy
Brief summary
The purpose of this study was to assess the safety and efficacy of Cotrifazid to treat uncomplicated resistant malaria and to compare the outcome with mefloquine or quinine+sulfadoxine/pyrimethamine (SP)
Detailed description
Design: Open-label, block-randomised, comparative, multicentric trial. Setting: Four primary care health facilities, two in urban and two in rural areas of Madang and East Sepik Province, Papua New Guinea. Participants: Patients of all ages with recurrent uncomplicated malaria Intervention: Random assignment to receive either Cotrifazid, mefloquine or the standard treatment of quinine+sulfadoxine/pyrimethamine (SP). Outcome measures: Incidence of clinical and laboratory adverse events; rate of clinical and/or parasitological failure at day 14
Interventions
DRUGCotrifazid vs mefloquine or quinine+SP
Sponsors
Papua New Guinea Institute of Medical Research
Swiss Tropical & Public Health Institute
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects \> 6 months of age who presented at the centres and who were diagnosed with malaria (history of fever, OptiMAL® test positive, no other major symptom) and who had already been treated for malaria in the 28 days before, could be included in the study, if the subject or legal guardian (for children) gave informed consent and if the clinician in charge would have given the standard treatment for resistant malaria independent of the study -
Exclusion criteria
A subject was not to be included if the clinician preferred to use quinine for whatever reason, if the patient had one of the symptoms or signs of complicated or severe malaria (i.e. history of recent convulsion, any neurological sign or impairment of consciousness, heavy vomiting, haemoglobinuria, respiratory distress, bleeding, circulatory collapse, shock, jaundice, haemoglobin \< 5 g/dl), had contra-indications for mefloquine (history of psychiatric disorder, epilepsy), or was pregnant. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical treatment failure rate on day 14. | — |
| Incidence of adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasite clearance time | — |
| Parasitological failure rate on day 14 | — |
| Occurrence of complications | — |
| Symptoms clearance time | — |
| Fever clearance time | — |
Countries
Papua New Guinea
Outcome results
None listed