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Antimicrobial Agents and Chemotherapy, July 2000, p. 1855-1859, Vol. 44, No. 7
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

A Randomized Controlled Comparison of Azithromycin and Ofloxacin for Treatment of Multidrug-Resistant or Nalidixic Acid-Resistant Enteric Fever

Nguyen Tran Chinh,1 Christopher M. Parry,2,* Nguyen Thi Ly,1 Huynh Duy Ha,3 Mai Xuan Thong,3 To Song Diep,3 John Wain,2 Nicholas J. White,2 and Jeremy J. Farrar2

Department of Infectious Diseases, Faculty of Medicine, University of Medicine and Pharmacy,1 and Wellcome Trust Clinical Research Unit,2 Centre for Tropical Diseases,3 Ho Chi Minh City, Vietnam

Received 8 November 1999/Returned for modification 27 February 2000/Accepted 3 April 2000

To examine the efficacy and safety of short courses of azithromycin and ofloxacin for treating multidrug-resistant (MDR, i.e., resistant to chloramphenicol, ampicillin, and cotrimoxazole) and nalidixic acid-resistant enteric fever, azithromycin (1 g once daily for 5 days at 20 mg/kg/day) and ofloxacin (200 mg orally twice a day for 5 days at 8 mg/kg/day) were compared in an open randomized study in adults admitted to a hospital with uncomplicated enteric fever. A total of 88 blood culture-confirmed patients were enrolled in the study (86 with Salmonella enterica serovar Typhi and 2 with S. enterica serovar Paratyphi A). Of these, 44 received azithromycin and 44 ofloxacin. A total of 68 of 87 (78%) isolates were MDR serovar Typhi, and 46 of 87 (53%) were nalidixic acid resistant. The MIC90 (range) of azithromycin was 8 (4 to 16) µg/ml for the isolates. The MIC90 (range) of ofloxacin for the nalidixic acid-sensitive isolates was 0.03 (0.015 to 0.06) µg/ml and for the nalidixic acid-resistant isolates it was 0.5 (0.25 to 1.0) µg/ml. There was no significant difference in the overall clinical cure rate with ofloxacin and azithromycin (38 of 44 [86.4%] versus 42 of 44 [95.5%]; P = 0.27) or in the patients infected with nalidixic acid-resistant typhoid (17 of 21 [81.0%] versus 24 of 25 [96.0%]; P = 0.16). However, patients with nalidixic acid-resistant typhoid treated with ofloxacin had a longer fever clearance time compared with those treated with azithromycin (174 [60 to 264] versus 135 [72 to 186] h; P = 0.004) and had positive fecal cultures after the end of treatment (7 of 17 [41%] versus 0 of 19 [0%]; P = 0.002). Both antibiotics were well tolerated. A 5-day course of azithromycin was effective for the treatment of enteric fever due to MDR and nalidixic-acid-resistant serovar Typhi, whereas the ofloxacin regimen chosen was less satisfactory for these strains.

* Corresponding author. Mailing address: Wellcome Trust Clinical Research Unit, Centre for Tropical Diseases, 190 Ben Ham Tu, District 5, Ho Chi Minh City, Vietnam. Phone: 848-8353954. Fax: 848-8353905. E-mail: cparry{at}hcm.vnn.vn.

Antimicrobial Agents and Chemotherapy, July 2000, p. 1855-1859, Vol. 44, No. 7
0066-4804/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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