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Comparison of Ciprofloxacin (7 Days) and Trimethoprim-Sulfamethoxazole (14 Days) for Acute Uncomplicated Pyelonephritis in Women a Randomized Trial

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Comparison of Ciprofloxacin (7 Days) and Trimethoprim-Sulfamethoxazole (14 Days) for Acute Uncomplicated Pyelonephritis in Women a Randomized Trial ORIGINAL CONTRIBUTION Comparison of Ciprofloxacin (7 Days) and Trimethoprim-Sulfamethoxazole (14 Days) for Acute Uncomplicated Pyelonephritis in Women A Randomized Trial David A. Talan, MD Context The optimal antimicrobial regimen and treatment duration for acute un- Walter E. Stamm, MD complicated pyelonephritis are unknown. Thomas M. Hooton, MD Objective To compare the efficacy and safety of a 7-day ciprofloxacin regimen and a 14-day trimethoprim-sulfamethoxazole regimen for the treatment of acute pyelo- Gregory J. Moran, MD nephritis in women. Thomas Burke, MD Design Randomized, double-blind comparative trial conducted from October 1994 Abdollah Iravani, MD through January 1997. Jonathan Reuning-Scherer, PhD Setting Twenty-five outpatient centers in the United States. Deborah A. Church, MD Patients Of 378 enrolled premenopausal women aged at least 18 years with clinical diagnosis of acute uncomplicated pyelonephritis, 255 were included in the analysis. N THE UNITED STATES AT LEAST Other individuals were excluded for no baseline causative organism, inadequate re- 250 000 episodes of acute pyelo- ceipt of study drug, loss to follow-up, no appropriate cultures, and other reasons. nephritis occur annually among Interventions Patients were randomized to oral ciprofloxacin, 500 mg twice per day adult women, resulting in as many for 7 days (with or without an initial 400-mg intravenous dose) followed by placebo Ias 100 000 hospitalizations.1,2 How- for 7 days (n = 128 included in analysis) vs trimethoprim-sulfamethoxazole, 160/800 ever, the optimal antimicrobial regi- mg twice per day for 14 days (with or without intravenous ceftriaxone, 1 g) (n = 127 men and duration of therapy for this in- included in the analysis). fection have not been established. Main Outcome Measure Continued bacteriologic and clinical cure, such that al- In contrast to the paucity of con- ternative antimicrobial drugs were not required, among evaluable patients through trolled treatment trials in women with the 4- to 11-day posttherapy visit, compared by treatment group. pyelonephritis, recent studies of women Results At 4 to 11 days posttherapy, bacteriologic cure rates were 99% (112 of 113) with uncomplicated lower urinary tract for the ciprofloxacin regimen and 89% (90 of 101) for the trimethoprim- infections have established that these sulfamethoxazole regimen (95% confidence interval [CI] for difference, 0.04-0.16; infections can be treated effectively with P = .004). Clinical cure rates were 96% (109 of 113) for the ciprofloxacin regimen antimicrobials for less than 7 to 14 and 83% (92 of 111) for the trimethoprim-sulfamethoxazole regimen (95% CI, 0.06- days.3-5 Three-day regimens of trimeth- 0.22; P = .002). Escherichia coli, which caused more than 90% of infections, was more frequently resistant to trimethoprim-sulfamethoxazole (18%) than to ciprofloxacin (0%; oprim-sulfamethoxazole or fluoroqui- P,.001). Among trimethoprim-sulfamethoxazole–treated patients, drug resistance was nolones appear to provide adequate associated with greater bacteriologic and clinical failure rates (P,.001 for both). Drug- cure rates, while being associated with related adverse events occurred in 24% of 191 ciprofloxacin-treated patients and in lower cost and fewer adverse effects 33% of 187 trimethoprim-sulfamethoxazole–treated patients, respectively (95% CI, than longer regimens. The current stan- −0.001 to 0.2). dard duration of therapy for acute un- Conclusions In our study of outpatient treatment of acute uncomplicated pyelo- complicated pyelonephritis is 14 days, nephritis in women, a 7-day ciprofloxacin regimen was associated with greater bac- but few studies of shorter-course teriologic and clinical cure rates than a 14-day trimethoprim-sulfamethoxazole regi- therapy for this infection have been un- men, especially in patients infected with trimethoprim-sulfamethoxazole–resistant strains. dertaken. Increasing antimicrobial re- JAMA. 2000;283:1583-1590 www.jama.com Author Affiliations and Financial Disclosures are listed MD, Olive View-UCLA Medical Center, 14445 Olive See also Patient Page. at the end of this article. View Dr, North Annex, Sylmar, CA 91342 (e-mail: Corresponding Author and Reprints: David A. Talan, [email protected]). ©2000 American Medical Association. All rights reserved. JAMA, March 22/29, 2000—Vol 283, No. 12 1583 Downloaded From: https://jamanetwork.com/ on 09/29/2021 SHORT-COURSE ANTIMICROBIAL REGIMENS FOR PYELONEPHRITIS sistance and concomitant reduced clini- of more than 229 µmol/L (2.6 mg/dL) or at days 3 to 5 during therapy, and at days cal efficacy of amoxicillin and ampicillin creatinine clearance level of less than 30 4 to 11 and 22 to 48 posttherapy (ie, fol- for urinary tract infections have been mL/min (0.50 mL/s); persistent vomit- lowing the end of the initial 14-day regi- observed for the last 2 decades, greatly ing; hospital admission; fluoroquino- men for each treatment group). Organ- limiting the use of these drugs for treat- lone, sulfaonamide, penicillin, or ceph- isms present in a concentration of 103 ment of cystitis and pyelonephritis.4 alosporin allergy; pregnancy or lactation; colony-forming units/mL or more were Recently, increasing in vitro resis- a systemic antimicrobial within the pre- identified using standard microbiologi- tance of uropathogens to trimethoprim- vious 72 hours; investigational drug ad- cal techniques. Antimicrobial suscepti- sulfamethoxazole has been reported in ministration within 30 days; and previ- bility testing was performed according the United States.6 However, the ex- ous enrollment in this study. to National Committee for Clinical Labo- tent of this resistance and its clinical im- ratory Standards laboratory proce- plications are unclear. Furthermore, the Study Procedures dures using the modified Kirby-Bauer current shift to outpatient manage- Subjects had a medical history and procedure or by microdilution.7,8 Pre- ment and emphasis on cost-saving strat- physical examination performed, in- therapy blood cultures, if positive, were egies make it timely to evaluate criti- cluding a pelvic examination. Those who repeated within 72 hours. cally treatment regimens for acute, met entry criteria and provided written uncomplicated pyelonephritis. informed consent had pretherapy blood Main Outcome Measures We conducted a multicenter, random- cultures (2 sets) and urine specimens Primary study outcomes were study drug ized,double-blind,outpatienttrialtocom- (collected by midstream clean catch or efficacy based on continued bacterio- pare the efficacy, safety, and relative costs bladder catheterization) obtained for cul- logic and clinical cure (such that no alter- of oral ciprofloxacin, 500 mg twice per ture and susceptibility testing. native antimicrobial therapy for uri- day for 7 days, and oral trimethoprim- Initial stratification to decide whether nary tract infection was prescribed) sulfamethoxazole, 160/800 mg twice per the initial dose of antimicrobial would through the 4- to 11-day posttherapy visit day for 14 days (with or without an ini- be given intravenously or orally was among all enrolled patients who were tial intravenous dose of ciprofloxacin or made by the treating physician. Sub- evaluable for efficacy analyses (efficacy- ceftriaxoneineachgroup)inwomenwith jects were then randomly assigned to re- valid group). Criteria for efficacy evalu- acute uncomplicated pyelonephritis. We ceive 500-mg tablets of ciprofloxacin ation were: (1) enrollment criteria for hypothesized that the 7-day ciproflox- (Cipro, Bayer Corporation Pharmaceu- acute uncomplicated pyelonephritis, (2) acin regimen would have equivalent tical Division, West Haven, Conn) or pretherapy growth of uropathogens of efficacy to the 14-day trimethoprim- 160/800-mg tablets of trimethoprim- 104 colony-forming units/mL or more sulfamethoxazole regimen and in vitro sulfamethoxazole (Bactrim, Roche Labo- (midstream clean catch) or of 103 colony- resistanceoftheinfectingpathogenwould ratories, Nutley, NJ). Subjects receiv- forming units/mL or more (catheteriza- be associated with decreased efficacy. ing an initial intravenous dose were tion); (3) study drug received 5 full days administered 400 mg of ciprofloxacin or more (unless clinical or bacterio- METHODS (ciprofloxacin group) or1gofceftriax- logic failure occurred requiring another Study Population one (trimethoprim-sulfamethoxazole antimicrobial); (4) no other systemic Premenopausal women aged at least 18 group, Rocephin, Roche Laboratories) antimicrobial use; and (5) 1 or more years with a clinical diagnosis of acute over 60 minutes. Antimicrobial in- posttherapy follow-up visits including uncomplicated pyelonephritis were en- fusions were identical and oral medi- repeat urine culture and measurement rolled at 25 outpatient centers (ie, emer- cations were encapsulated in opaque of pyuria. Patients remained in the study gency departments, clinics, and offices) gelatin capsules (#000) for blinding pur- whether the pretherapy blood or urine throughout the United States between poses. Patients who were unable to tol- isolate was subsequently found to be October 1994 and January 1997. The erate oral medications after up to 12 resistant to either or both study drugs. study was approved by each institu- hours of observation were discontin- Continued bacteriologic cure was de- tional review board. Eligible patients had ued from the study. All patients re- fined as pathogen growth of less than 104 flank pain and/or costovertebral angle ceived 1 capsule twice per day for 14
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