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Open Access Research article

A randomized, parallel study of the safety and efficacy of 45 mg primaquine versus 75 mg bulaquine as gametocytocidal agents in adults with blood schizonticide-responsive uncomplicated falciparum malaria [ISCRTN50134587]

NJ Gogtay1, KD Kamtekar1, SS Dalvi1, SS Mehta2, AR Chogle3, U Aigal3 and NA Kshirsagar1*

Author Affiliations

1 Department of Clinical Pharmacology, Seth G.S. Medical College and K.E.M hospital. Parel, Mumbai 400 012, India

2 Department of Medicine, Seth G.S Medical College & K.E.M Hospital, Parel, Mumbai 400012, India

3 Kasturba Hospital for Infectious diseases, Sane Guruji Marg, Mumbai 400011, India

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BMC Infectious Diseases 2006, 6:16  doi:10.1186/1471-2334-6-16

Published: 1 February 2006

Abstract

Background

The WHO recommends that adults with uncomplicated P. falciparum successfully treated with a blood schizonticide receive a single dose of primaquine (PQ) 45 mg as a gametocytocidal agent. An earlier pilot study suggested that 75 mg of bulaquine (BQ), of which PQ is a major metabolite, may be a useful alternate to PQ.

Methods

In a randomized, partial blind study, 90 hospitalized adults with Plasmodium falciparum malaria that was blood schizonticide-responsive and a gametocytemia of > 55/μl within 3 days of diagnosis were randomized to receive single doses of either PQ 45 mg or BQ 75 mg on day 4. We assessed gametocytemia on days 8, 15, 22 and 29 and gametocyte viability as determined by exflagellation (2° end point) on day 8.

Results

On day 8, 20/31 (65%) primaquine recipients versus 19/59 (32%) bulaquine recipients showed persistence of gametocytes (P = 0.002). At day 15 and beyond, all patients were gametocyte free. On day 8, 16/31 PQ and 7/59 BQ volunteers showed gametocyte viability (p = 0.000065).

Conclusion

BQ is a safe, useful alternate to PQ as a Plasmodium falciparum gametocytocidal agent and may clear gametocytemia faster than PQ.