title: A double-blind, randomized study of azithromycin compared to chloroquine for the treatment of Plasmodium vivax malaria in India.
abstract: Azithromycin has demonstrated activity in a prevention of Plasmodium vivax infection, but no controlled treatment studies have been performed. We conducted a double-blinded trial in P. vivax malaria in which patients were randomized to either azithromycin 1,000 mg q.d. x 3 or chloroquine 600 mg q.d. x 2 then 300 mg on Day 3 followed by primaquine on Days 7 through 20. Eighty-five of 97 (88%) of those on azithromycin and 101 of 102 (99%) of those on chloroquine [difference 11%; 95% CI: -18, -4] were clinically cured at Day 7. The Day 28 results were similar [89% versus 99%, azithromycin versus chloroquine, respectively]. Parasitologic success was seen in 81 of 97 (84%) on azithromycin and 100 of 102 (98%) on chloroquine [difference 14%; 95% CI: -22, -6]. The median parasite clearance time was 55 hours on azithromycin and 20 hours on chloroquine (P < 0.001). Drug-related adverse events were seen in 13 of 98 (13%) on azithromycin and 24 of 102 (24%) on chloroquine (P = 0.062). Resolution of parasitemia was significantly faster with chloroquine compared with azithromycin, but azithromycin was better tolerated. These data provide support for further study of azithromycin to better define its role in the treatment of P. vivax malaria, either alone as second-line treatment or in combination with other active therapies.
authors.affiliation: Pfizer Global Research and Development, New London, Connecticut 06320, USA. michael.w.dunne@pfizer.com
authors.forename: Michael W
authors.initials: MW
authors.lastname: Dunne
authors.forename: Neeru
authors.initials: N
authors.lastname: Singh
authors.forename: Manmohan
authors.initials: M
authors.lastname: Shukla
authors.forename: Neena
authors.initials: N
authors.lastname: Valecha
authors.forename: Prabhash C
authors.initials: PC
authors.lastname: Bhattacharyya
authors.forename: Kanta
authors.initials: K
authors.lastname: Patel
authors.forename: Manoj Kumar
authors.initials: MK
authors.lastname: Mohapatra
authors.forename: Jitendra
authors.initials: J
authors.lastname: Lakhani
authors.forename: C Usha
authors.initials: CU
authors.lastname: Devi
authors.forename: Tridibes
authors.initials: T
authors.lastname: Adak
authors.forename: Vas
authors.initials: V
authors.lastname: Dev
authors.forename: Rajpal S
authors.initials: RS
authors.lastname: Yadav
authors.forename: Chitra
authors.initials: C
authors.lastname: Lele
authors.forename: Kiran
authors.initials: K
authors.lastname: Patki
mesh_terms: D000328:Adult; D000368:Aged; D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000627:therapeutic use*; D002738:Chloroquine / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016780:Malaria, Vivax / Q000097:blood / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D008875:Middle Aged; D018512:Parasitemia / Q000097:blood / Q000188:drug therapy / Q000469:parasitology; D010966:Plasmodium vivax / Q000187:drug effects; D011319:Primaquine / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D017963:Azithromycin; D002738:Chloroquine; D011319:Primaquine