• 1

    Fryauff DJ, Leksana B, Masbar S, Wiady I, Sismadi P, Nagesha HS, Syafruddin, Atmosoedjono S, Bangs MJ, Baird JK, 2002. The drug sensitivity and transmission dynamics of human malaria on Nias Island, North Sumatra, Indonesia. Ann Trop Med Parasitol 96 :447–462.

    • Search Google Scholar
    • Export Citation
  • 2

    Soto J, Toledo J, Gutierrez P, Luzz M, Llinas N, Cedeno N, Dunne M, Berman J, 2001. Plasmodium vivax clinically resistant to chloroquine in Columbia. Am J Trop Med Hyg 65 :90–93.

    • Search Google Scholar
    • Export Citation
  • 3

    Baird JK, 2004. Chloroquine resistance in Plasmodium vivax. Antimicrob Agents Chemother 48 :4075–4083.

  • 4

    Taylor WR, Ritchie R, Fryauff DJ, Picarima H, Ohrt C, Tang D, Braitman D, Murphy GS, Widjaja H, Tjitra E, Ganjar A, Jones TR, Basri H, Berman J, 1999. Malaria prophylaxis using azithromycin: a double blind placebo controlled trial in Irian Jaya, Indonesia. Clin Infect Dis 28 :74–81.

    • Search Google Scholar
    • Export Citation
  • 5

    Kremsner PG, 1990. Clindamycin in malaria treatment. J Antimicrob Chemo 25 :9–14.

  • 6

    Pukrittayakamee S, Clemens R, Chantra A, Nontprasert A, Luknam T, Looareesuwan S, White NJ, 2001. Therapeutic responses to antibacterial drugs in vivax malaria. Trans R Soc Trop Med Hyg 95 :524–528.

    • Search Google Scholar
    • Export Citation
  • 7

    Clyde DF, Gilman RH, McCarthy VC, 1975. Antimalarial effects of clindamycin in man. Am J Trop Med Hyg 24 :369–370.

  • 8

    Ranque S, Badiaga S, Delmont J, Brouqui P, 2002. Triangular test applied to the clinical trial of azithromycin against relapses in Plasmodium vivax infections. Malaria J 1 :13.

    • Search Google Scholar
    • Export Citation
 
 
 

 

 
 
 

 

 

 

 

 

 

A DOUBLE-BLIND, RANDOMIZED STUDY OF AZITHROMYCIN COMPARED TO CHLOROQUINE FOR THE TREATMENT OF PLASMODIUM VIVAX MALARIA IN INDIA

View More View Less
  • 1 Pfizer Global Research and Development, New London, Connecticut; Malaria Research Center, Jabalpur, India; Malaria Research Center, Delhi, India; Down Town Hospital, Guwahati, India; Baroda, India; MKCG Medical College, Berhampur, India; Pramukhswami Medical College, Karamsad, India; Malaria Research Center, Sonapur, India; Malaria Research Center, Nadiad, India; Pfizer Global Research and Development, Mumbai, India

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. × 3 or chloroquine 600 mg q.d. × 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.

Author Notes

Reprint requests: Michael W. Dunne, MD, Pfizer Global Research and Development, 50 Pequot Avenue, New London, CT 06320, Telephone: 860-732-3739, Fax: 860-715-9250, E-mail: michael.w.dunne@pfizer.com.
Save