Falciparum Malaria, Vivax Malaria
Conditions
Keywords
Falciparum, Vivax, Papua, Chloroquine, Sulphadoxine-pyrimethamine
Brief summary
Multidrug resistant strains of P.falciparum and P.vivax are becoming increasingly prevalent in the Asia Pacific rim. To determine the efficacy of locally recommended antimalarial protocols in Papua, Indonesia, consecutive patients presenting to a rural clinic were enrolled into a prospective efficacy study. Patients with uncomplicated falciparum malaria were treated with chloroquine plus sulfadoxine-pyrimethamine and those with vivax malaria with chloroquine monotherapy. Patients failing therapy received unsupervised oral quinine +/- doxycycline for 7 days. Follow-up was continued for 42 days for falciparum malaria and 28 days for vivax malaria. The study hypothesis was that current recommended antimalarial protocols were no longer effective.
Interventions
DRUGChloroquine and sulphadoxine-pyrimethamine
Sponsors
Wellcome Trust
National Health and Medical Research Council, Australia
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Menzies School of Health Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
-Male and female patients at least one 1year of age and weighing more than 10kg. * -Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia). * -Fever (axillary temperature \>37.5oC) or history of fever in the last 48 hours. * -Able to participate in the trial and comply with the clinical trial protocol * -Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent
Exclusion criteria
* Pregnancy or lactation * -Inability to tolerate oral treatment * -Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment * -Known hypersensitivity or allergy to artemisinin derivatives * -Serious underlying disease (cardiac, renal or hepatic) * -Parasitaemia \>4%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 42 day cure rate; corrected for reinfection by PCR genotyping. | — |
| • Overall Cure Rate at Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of patients with a negative slide at Days 1, 2 and 3 | — |
| • Gametocyte Carriage. Anti-gametocyte activity will be measured by the proportion of patients with a peripheral gametocytaemia between day 7 to day 28. | — |
| • Overall day 28 cure rate for P.falciparum. This will allow comparison with previous historical data at this time point. | — |
| • Late Treatment Failure (LTF) | — |
| • Early Treatment Failure (ETF) | — |
| • Parasite reduction. Parasite reduction will be calculated at Days 1, 2 and 3 after initiation of trial treatment as percentage of parasites/uL compared to parasite density before the first dose of treatment. | — |
Countries
Indonesia
Outcome results
None listed