title: 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].
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/microl 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 degrees 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).
  
  
  CONCLUSIONS
  BQ is a safe, useful alternate to PQ as a Plasmodium falciparum gametocytocidal agent and may clear gametocytemia faster than PQ.
authors.affiliation: Department of Clinical Pharmacology, Seth G.S. Medical College and K.E.M Hospital, Parel, Mumbai 400 012, India. njgogtay@hotmail.com
authors.forename: N J
authors.initials: NJ
authors.lastname: Gogtay
authors.forename: K D
authors.initials: KD
authors.lastname: Kamtekar
authors.forename: S S
authors.initials: SS
authors.lastname: Dalvi
authors.forename: S S
authors.initials: SS
authors.lastname: Mehta
authors.forename: A R
authors.initials: AR
authors.lastname: Chogle
authors.forename: U
authors.initials: U
authors.lastname: Aigal
authors.forename: N A
authors.initials: NA
authors.lastname: Kshirsagar
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000627:therapeutic use*; D004318:Doxycycline / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D008875:Middle Aged; D018512:Parasitemia / Q000188:drug therapy / Q000469:parasitology; D010963:Plasmodium falciparum / Q000187:drug effects*; D011319:Primaquine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use*; D011803:Quinine / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D011803:Quinine; D011319:Primaquine; D004318:Doxycycline; C063469:bulaquine