Effect of Primaquine in the patients of P.vivax and P.falciparum malaria.

Evaluation of Primaquine Pharmacokinetics in the patients of P.vivax and P.falciparum malaria.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001040

Enrollment

Registered

2010-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: For P. falciparum: Quinine + Doxycycline + Primaquine: 10mg/kg quinine and doxycycline for 3 days + single dose 45mg Primaquine (stat) Intervention2: For P. vivax: Chloroquine + Primaqu

Eligibility

Inclusion criteria

Inclusion criteria: -Patients with confirmed cases of vivax and falciparum malaria (asexual forms) by microscopy on a thin blood smear (parasite density >300/mm3) -Patients giving written informed consent to participate in this study. -Male and female patients aged 18 -65 years. -Patients with axillary temperature >37.50C (>99.50F) -Patients with chills, nausea, vomiting, headache, malaiase and any 2 of the following signs/symptoms of uncomplicated malaria (diarrhea, anorexia, abdominal cramps, myalgia, arthralgia) -Normal G-6-P-D status as assessed by qualitative and quantitative tests.

Exclusion criteria

Exclusion criteria: -Patients with history of hypersensitivity to chloroquine, quinine, primaquine or aminoquinoline derivatives or other similar drugs as assessed by history. -Pregnant (female patients with prescribed pregnancy test positive) or lactating women. -Patients with severe or complicated malaria or mixed malarial infection. -Patients taking cardioactive drug or potentially hemolytic drugs or bone marrow depressants. -Patients on another investigational drug. -Patients with concomitant illness (cardiac, hepatic or renal diseases) -Patients previously treated with any other antimalarial therapy except chloroquine -Patients with glucose 6-phosphate dehydrogenase deficiency

Design outcomes

Primary

Measure	Time frame
To determine the pharmacokinetic parameters of primaquine in patients suffering from P.vivax and P.falciparum malaria. (Cmax, tmax, AUCss,t, t1/2)Timepoint: Day 1, 2, 3 and 14	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactPooja Chheda

Nil

njgogtay@hotmail.com022-24133767

Outcome results