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Clinical Evaluation of the Tolerability and Efficacy of Trovafloxacin Compared with Sparfloxacin in the Treatment of Lower Respiratory Tract Infections

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Abstract

Objective: To evaluate the clinical tolerability and efficacy of trovafloxacin compared with sparfloxacin in the treatment of lower respiratory tract infections.

Design: This was a randomised, double-blind, controlled, parallel study.

Participants and Interventions: 92 patients with lower respiratory tract infection were enrolled in three centres. 45 patients received trovafloxacin 200mg once daily orally for 10 days and 43 patients received sparfloxacin 400mg on the first day and 200mg once daily orally for 9 days. Clinical evaluation was performed for fever, dyspnoea, pulmonary symptoms, cough and sputum on days 1, 3, 6 and 12 of the study along with bacteriological evaluation on days 1 and 12. Any adverse effects were also recorded during the study period.

Results: There was a significant reduction in the severity of symptoms from day 4 until the end of the study. Clinical cure or improvement was seen in 87 and 95% of the trovafloxacin and sparfloxacin groups, respectively. Bacteriological eradication rates were 84 and 89% for the trovafloxacin and sparfloxacin groups, respectively. The number of adverse effects was 10 and 13 reported by 10 and 13 patients in the trovafloxacin and sparfloxacin groups, respectively.

Conclusions: Trovafloxacin is well tolerated and effective in the treatment of lower respiratory tract infections in a dosage of 200mg daily. It was observed that the efficacy and tolerability of trovafloxacin is comparable to that of sparfloxacin (200mg daily, with a loading dose of 400mg on the first day) in the treatment of lower respiratory tract infections. However, further studies are needed to confirm this.

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Acknowledgements

We gratefully acknowledge the assistance of Dr Reddy’s Laboratories, Hyderabad, for financial support given to conduct the study.

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Authors and Affiliations

  1. Department of Clinical Pharmacology and Therapeutics, Nizam’s Institute of Medical Sciences, Panjagutta, Hyderabad, 500 082, AP, India

    Jagdish Chandra Shobha Associate Professor & T. Ramesh Kumar

  2. Government Hospital of Thoracic Medicine, Chennai, India

    N. Deivanayagam & C. Chandra Sekhar

  3. Department of Respiratory Medicine, Chennai, India

    Raj B. Singh

  4. Consultant Chest Physician, Hyderabad, India

    Pradyut Waghray

  5. Dr Reddy’s Laboratories, Hyderabad, India

    P. Aravinda Babu & Jaydip Bhaduri

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  1. Jagdish Chandra Shobha Associate Professor
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  2. T. Ramesh Kumar
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  3. N. Deivanayagam
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  4. Raj B. Singh
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Shobha, J.C., Kumar, T.R., Deivanayagam, N. et al. Clinical Evaluation of the Tolerability and Efficacy of Trovafloxacin Compared with Sparfloxacin in the Treatment of Lower Respiratory Tract Infections. Clin. Drug Investig. 20, 95–100 (2000). https://doi.org/10.2165/00044011-200020020-00004

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