A clinical trial to study the effect of primaquine conventional release tablet and primaquine sustained release tablet in prevention of relapse of plasmodium vivax malaria.

Phase 3

Completed

Brief Summary: This study is a randomized, double blind, parallel group, multicentre trial comparing the efficacy and safety of primaquine-Sr tablet and primaquine conventional release tablets in the preventiona of relapse P.vivax malaria in 360 patients that will be conducted at 7 centres in India. The primary efficacy outcome will be no occurenece of asexual forms of parasites in the blood 6 months after primaquine therapy. Secondary outcome will be occurence of parasites with syptoms of malaria after six months of primaquine therapy.

Recruitment & Eligibility

Inclusion Criteria

1.Male and female patients aged 18 -65 years.2.Patients with confirmed cases of P.
vivax malaria (asexual forms) by microscopy on a thin and thick blood smear with parasite count of >/=1,000/µL of blood.3.Patients with axillary temperature >/= 37.5 °C and with clinical signs and symptoms of malaria.4. Patients giving written informed consent to participate in this study.5.patients willing to undergo folloe-up for 2-6 months.

Exclusion Criteria

Patients with Mixed malarial infection.
2.Patients with body weight 40 kg.
3.Patients with severe or complicated malaria.
4.Patients with glucose 6-phosphate dehydrogenase deficiency.
5.Patients with a history of dark urine or significant hemoglobinuria related to Primaquine treatment during the course of a pervious episode of malaria.
6.Patient with known history of methomoglobinemia.
7.Patients taking cardioactive drug or potentially hemolytic drugs.
8.Patients with concomitant illness (cardiac, hepatic or renal diseases-blood urea nitrogen (BUN) 20mg/dl or blood urea 40mg/dl, hepatic SGPT or SGOT 2.5 x ULN, serum bilirubin 2mg/dl and serum creatinine 1.5mg/dl)).
Patients previously treated with any other antimalarial therapy except chloroquine.
10.Patients showing any significant abnormality (clinical or laboratory) on pre-trial screening in the opinion of the investigator.
Patients with protracted vomiting and oliguria.
12.Patients with systolic BP 160 mm Hg and/or diastolic BP 110 mm Hg. 13.Patients with acute exacerbations of systemic diseases, having a tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus.
15.Patients with history of hypersensitivity to chloroquine, primaquine or aminoquinoline derivatives, or other similar drugs.
Patient having any concomitant medication which may interact with study drugs.
17.Patients on another investigational drug.
Patients unable to tolerate oral medication and known history of alcoholism.
19.Pregnant or lactating women.

Primary Outcome Measures

Name	Time	Method
No occurrence of microscopically proven P. vivax malaria (asexual forms) after treatment with primaquine.	Parasite count will be measured every 12 hours during 3 days of chloroquine therapy untill negative and then on day 7, 14, 21, 28 and then monthly up to 6 months. After day 14 parasite count will be measured only if the clinical signs and syptoms of malaria are present.

Secondary Outcome Measures

Name	Time	Method
Comparative safety	At the end of therapy on day 14

Locations (10): Dr. S.N. Medical College and Hospital
🇮🇳
Jodhpur, RAJASTHAN, India
Grant Medical College and J.J. Group of Hospitals
🇮🇳
Mumbai, MAHARASHTRA, India
IPGMER and SSKM Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Kasturba Hospital for Infectious Diseases
🇮🇳
Mumbai, MAHARASHTRA, India
Kothari Medical and Research Institute
🇮🇳
Bikaner, RAJASTHAN, India
Mahatma Gandhi Mission Medical College, Jaipur
🇮🇳
Jaipur, RAJASTHAN, India
Padmashree, Dr. D.Y.patil Medical College and Hospital
🇮🇳
Pune, MAHARASHTRA, India
Seth. G.S. Medical College and K.E.M. Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Siddhartha Medical College
🇮🇳
Medical, India
T.N. Medical College and B.Y.L. Nair Hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Dr. S.N. Medical College and Hospital
🇮🇳Jodhpur, RAJASTHAN, India
Dr Arvind Kumar Jain
Principal investigator
9314743757
drarvindjain@gmail.com