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

Received January 12, 2005. Accepted for publication June 10, 2005.

Disclosure: Michael Dunne wishes to disclose that he is an employee of Pfizer Inc., the makers of azithromycin. This statement is being made in the interest of full disclosure and not because the author considers this to be a conflict of interest.

This study was presented to the American Society of Tropical Medicine and Hygiene, Atlanta, Georgia, November 2001.

Financial support: This study was funded by Pfizer Global Research and Development, Inc.

^* Address correspondence to Michael W. Dunne, MD, Pfizer Global Research and Development, 50 Pequot Avenue, New London, CT 06320. E-mail: michael.w.dunne{at}pfizer.com

Authors’ addresses: Michael W. Dunne, Pfizer Global Research and Development, 50 Pequot Avenue, New London, CT 06320, E-mail: michael.w.dunne{at}pfizer.com. Neeru Singh, Manmohan Shukla, C. Ushi Devi, and Tridibes Adak, Malaria Research Center, Jabalpur, India. Neena Valecha, Malaria Research Center, Delhi, India. Prabhash C. Bhattacharyya, Down Town Hospital, Guwahati, India. Kanta Patel, Baroda, India. Manoj Kumar Mohapatra, MKCG Medical College, Berhampur, India. Jitendra Lakhani, Pramukhrwami Medical College, Karamsad, India. Vas Dev, Malaria Research Center, Sonapur, India. Rajpal S. Yadav, Malaria Research Center, Nadiad, India. Chitra Lele and Kiran Patki, Pfizer, Inc., Mumbai, India.

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{at}pfizer.com.

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