0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
Articles |

Empiric Treatment of Acute Diarrheal Disease with Norfloxacin: A Randomized, Placebo-Controlled Study

Johan Wiström, MD; Marianne Jertborn, MD, PhD; Erik Ekwall, MD, PhD; Karin Norlin, MD, PhD; Bo Söderquist, MD; Anders Strömberg, MD, PhD; Rolf Lundholm, MD; Harriet Hogevik, MD; Lillemor Lagergren; Gunnar Englund, ED; and S. Ragnar Norrby, MD, PhD
[+] Article and Author Information

Grant Support: By a grant from Astra Arcus AB, Södertälje, Sweden.

Requests for Reprints: Johan Wiström, MD, Department of Infectious Diseases, University of Umeå, Regional Hospital of Umeå, S-901 85 Umeå, Sweden.

Current Author Addresses: Dr. Wiström: Department of Infectious Diseases, University of Umeå, Regional Hospital of Umeå, S-901 85 Umeå, Sweden.

Drs. Jertborn and Hogevik: Department of Infectious Diseases, Östra sjukhuset, S-416 85 Gothenburg, Sweden.

Dr. Ekwall: Roslagstulls sjukhus, Box 5651, S-114 89 Stockholm, Sweden.

Drs. Norlin and Norrby: Department of Infectious Diseases, Lasarettet, S-221 85 Lund, Sweden.

Dr. Söderquist: Department of Infectious Diseases, Örebro Medical Centre Hospital, S-701 85 Örebro, Sweden.

Dr. Strömberg: Department of Infectious Diseases, Danderyds sjukhus, S-182 88 Danderyd, Sweden.

Mrs. Lagergren and Mr. Englund: Astra Arcus AB, S-151 85 Södertälje, Sweden.

Dr. Lundholm: Department of Clinical Bacteriology, University of Umeå, Regional Hospital of Umeå, S-901 85 Umeå, Sweden.


Swedish Study Group*


© 1992 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1992;117(3):202-208. doi:10.7326/0003-4819-117-3-202
Text Size: A A A

Objective: To evaluate the clinical and microbiologic efficacy and safety of norfloxacin for acute diarrhea.

Design: Double-blind, placebo-controlled, randomized clinical multicenter trial.

Setting: Six departments of infectious disease.

Participants: Patients 12 years of age or older with a history of acute diarrhea lasting 5 or fewer days. Eighty-five percent of patients (511/598) were evaluable for efficacy. Of these evaluable patients, 70% had traveled abroad within the previous 6 weeks.

Interventions: Patients received either norfloxacin, 400 mg, or placebo twice daily for 5 days.

Measurements: Enteric pathogens were isolated in 51% of the evaluable patients: Campylobacter species in 29%, Salmonella species in 16%, Shigella species in 3.5%, and other pathogens in 2.6%.

Results: Norfloxacin had a favorable overall effect compared with placebo (cure rate, 63% compared with 51%; P = 0.003). There were statistically favorable effects in culture-positive patients, patients with salmonellosis, and severely ill patients but not in culture-negative patients or patients with campylobacteriosis or shigellosis. A significant difference was noted between norfloxacin and placebo in median time to cure among all evaluable patients (3 compared with 4 days, P = 0.02) and in patients with campylobacteriosis (3 compared with 5 days, P = 0.05). Culture-positive, but not culture-negative patients, in the norfloxacin group had significantly fewer loose stools per day compared with patients in the placebo group from day 2 onward (P < 0.01). Norfloxacin was significantly less effective than placebo in eliminating Salmonella species on days 12 to 17 (18% compared with 49%, P = 0.006), whereas the opposite was true for Campylobacter species (70% compared with 50%, P = 0.03). In six of nine patients tested, norfloxacin-resistant Campylobacter species (MIC, ≥ 32 µg/mL) appeared after norfloxacin treatment.

Conclusion: Empiric treatment reduced the intensity and, to some extent, the duration of symptoms of acute diarrhea. The effect was restricted to patients who had bacterial enteropathogens or who were severely ill. The clinical usefulness of this treatment is limited by the fact that norfloxacin seems to delay the elimination of salmonella and to induce resistance in campylobacter.

Figures

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Related Articles
Related Point of Care
Topic Collections
PubMed Articles
Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)