Health Condition 1: B519- Plasmodium vivax malaria without complication
Conditions
Interventions
Intervention1: Primaquine 0.50mg/kg/day: Primaquine 0.50mg/kg/day for 7 days given once a day orally
Control Intervention1: Primaquine 0.25 mg/kg/day: Primaquine 0.25 mg/kg/day for 14 days given once
Sponsors
ICMR National Institute of Malaria Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.P. vivax (asexual) malaria monoinfection confirmed by microscopy on a thin and thick blood smear 2.Age 16 years and over of either gender. 3.Fever > 37.5°C axillary, or a history of fever within 48 hours 4.Female patients of child-bearing potential are included if they are non-lactating and willing to use contraceptive methods during the study period. Non-child bearing potential defined as: 4.1 post-menopausal (12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL), pre-menopausal and has had a hysterectomy or a bilateral oophorectomy (removal of the ovaries) or a bilateral tubal ligation with medical report verification or, 4.2 Child-bearing potential, has a negative urine pregnancy test at screening, and agrees to comply with one of the following during the treatment stage of the study and for a period of 90 days after stopping study drug: 4.2.1 Use of oral contraceptive, either combined or progesterone alone (if no contraindications to oral contraceptives exist). 4.2.2 Barrier contraceptive if oral contraceptives are contraindicated 4.2.3 Use of an intrauterine device. 5.Willing to give informed consent. 6.Willing to comply with protocol instructions and duration of follow up. 7.Only patients living in and around the site facilities will be enrolled in the study to facilitate follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with G6PD activity less than 30% of the adjusted male median (AMM), tested by UV spectrophotometry. 2.Patients with mixed infection with P. vivax and P. falciparum (e.g. identified by Giemsa-stained smear or rapid diagnostic test). 3.Patient with body weight less than 40 kg. 4.Severe P. vivax malaria defined as per Indian National Guidelines criteria (Appendix I). 5.Haemoglobin 6.Cannot tolerate oral treatment 7.History of haemolytic anaemia or methemoglobinemia or blood transfusion within 90 days 8.Pregnant and lactating females. 9.Known allergy to chloroquine, primaquine or any other related drugs. 10.Evidence of gastro-intestinal dysfunction that could alter absorption or motility (e.g., diarrhoea defined as >3 episodes of watery stools in the previous 24 h or patients who have had three episodes of vomiting within 24 h prior to screening). 11.Use of concomitant medications that could induce haemolysis or haemolytic anaemia or depressants of myeloid element of the bone marrow. 12.Any anti-malarial treatment taken 1 month prior to enrolment. 13.Ongoing prophylaxis with drugs having anti-malarial activity 14.Participation in any other investigational drug study of at least 3 months prior to screening 15.Any other underlying disease that could compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, HIV, Hepatitis, tuberculosis, Splenectomy conducted earlier as confirmed by history or clinical examination; evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine diseases, malignancy, or other abnormalities. 16.Retinal/visual field defects or auditory defects and history of psoriasis and porphyria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •The incidence risk of symptomatic P. vivax malaria Timepoint: Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence risk of any (symptomatic and asymptomatic) P. vivax malariaTimepoint: Day 28, till month 6;The proportion of patients vomiting their medicationTimepoint: Within 1 hour of administration;The proportion of adverse events and serious adverse eventsTimepoint: throughout study period;The incidence risk of severe anaemia (Hb 8g/dl) and/ or the risk of blood transfusionTimepoint: throughout study period;Risk of greater than 25% fall in haemoglobin on any day of treatmentTimepoint: throughout study period;Gastrointestinal (GI) tolerability - incidence of abdominal pain, heartburn, diarrhoea, constipation, nausea and vomitingTimepoint: throughout study period;Ophthalmic safety - incidence of corneal deposits, retinal and visual field abnormalities.Timepoint: throughout study period | — |
Countries
India
Contacts
Public ContactDr Manju Rahi
ICMR-National Institute of Malaria Research
Outcome results
None listed