Abstract | BACKGROUND AND PURPOSE: PATIENTS AND METHODS: In this open-label, single-arm study 20 adult patients (18 females, 2 males) with positive urine culture were treated orally with nitrofurantoin sustained release 100 mg twice daily for 7 days. Urinary nitrofurantoin concentrations were determined at baseline and day 4 of the study. Primary endpoint was the antimicrobial efficacy of nitrofurantoin at 12 to 16 days after baseline, assessed by changes in urine culture results. RESULTS: In the patient population treated per protocol, primary endpoint analysis revealed a microbial eradication rate of 92.3%. At 35 to 42 days, the eradication rate was 83.3%. At these times, all patients in the per protocol population were free of symptoms. In patients with complicating factors, e.g. diabetic polyneuropathy, both antimicrobial and clinical efficacy appeared to be reduced. Urinary nitrofurantoin concentrations were mostly above minimum inhibitory concentrations of the isolated uropathogens. The study drug was generally well tolerated. Most frequent drug-related adverse event was mild headache, occurring in 10.8% of patients. Two patients discontinued the study due to rash. CONCLUSION: The results of the present study indicate good antimicrobial and clinical efficacy of nitrofurantoin in the treatment of acute uncomplicated urinary tract infections as well as acceptable tolerability in adults.
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Authors | Arturo Mendoza-Valdes, Alejandra Rosete, Esteban Rios Bueno, Adrian Frentzel, Sonja Trapp, Wilhelm Kirch, Edgar A Mueller |
Journal | Medizinische Klinik (Munich, Germany : 1983)
(Med Klin (Munich))
Vol. 105
Issue 10
Pg. 698-704
(Oct 2010)
ISSN: 1615-6722 [Electronic] Germany |
Vernacular Title | Antimikrobielle und klinische Wirksamkeit von Nitrofurantoin in der Behandlung akuter Infekte der unteren ableitenden Harnwege bei Erwachsenen. |
PMID | 20981588
(Publication Type: English Abstract, Journal Article)
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Chemical References |
- Anti-Infective Agents, Urinary
- Delayed-Action Preparations
- Nitrofurantoin
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Topics |
- Administration, Oral
- Adult
- Aged
- Anti-Infective Agents, Urinary
(adverse effects, pharmacokinetics, therapeutic use)
- Bacteriuria
(drug therapy, urine)
- Delayed-Action Preparations
- Drug Administration Schedule
- Female
- Humans
- Male
- Metabolic Clearance Rate
(physiology)
- Mexico
- Middle Aged
- Nitrofurantoin
(adverse effects, pharmacokinetics, therapeutic use)
- Recurrence
- Treatment Outcome
- Urinary Tract Infections
(drug therapy, urine)
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