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Clinical Trials/CTRI/2022/12/048283
CTRI/2022/12/048283
Recruiting
Phase 3

A multi-center randomized controlled trial to compare the efficacy, safety, and tolerability of high dose, short course Primaquine–A pilot study

ICMR National Institute of Malaria Research0 sites0 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
ICMR National Institute of Malaria Research
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
ICMR National Institute of Malaria Research

Eligibility 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.

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 \<8 g/dl to be measured by Hb auto analyser.
  • •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).

Outcomes

Primary Outcomes

Not specified

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