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Background and Objectives <p>Respiratory tract infections and skin and soft-tissue infections are some of the most common causes of outpatient visits. Upper respiratory tract infections (URTIs) are the most common type of infection globally, as well as in India. In 2019, its global incidence was 17.2 billion. Additionally, the Infectious Diseases Society of America 2012 guidelines for the management of Group A streptococcal pharyngitis strongly recommend penicillin or amoxicillin for individuals without penicillin allergy. Therefore, we conducted this study to assess the real-world safety and efficacy of a fixed-dose combination of cephalexin extended release and clavulanate potassium (cephalexin CV) in patients with URTIs and uncomplicated skin and soft-tissue infections (uSSTIs).</p> Methods <p>In this phase IV, multicentre, open-label, single-arm study, patients with URTIs and uSSTIs&#xa0;were prescribed cephalexin CV (375 mg + 125 mg or 750 mg + 125 mg for severe infection) orally twice daily for 10 days. Patients were assessed for adverse events (AEs), clinical success defined as a clinical cure or clinical improvement, and microbiological success defined as a microbiological outcome of documented eradication or presumed eradication at the end of the study.</p> Results <p>A total of 230 patients were enrolled, 115 patients each with URTIs and uSSTIs. Only eight AEs were reported; seven were treatment-emergent AEs. In the URTI group, 1/115 (0.9%) patients reported one treatment-emergent AE and in the uSSTI group, 6/115 (5.2%) patients reported six treatment-emergent AEs. The most commonly reported treatment-emergent AE was diarrhoea. Three events of diarrhoea were related to the treatment (one in the URTI group and two in the uSSTI group). All AEs were of mild intensity and no serious AEs were reported. All patients with URTIs and 113 (98.3%) patients with uSSTIs showed clinical success; 16 (100%) patients with URTIs and 59 (96.7%) patients with uSSTIs&#xa0;showed microbiological success.</p> Conclusions <p>In this real-world study, the fixed-dose combination of cephalexin CV was safe, well tolerated and efficacious in terms of clinical and microbiological success for the treatment of URTIs and uSSTIs. In the current era of antimicrobial resistance, the fixed-dose combination of cephalexin CV can be an alternative therapeutic option.</p> Clinical Trial Registration <p>This study was prospectively registered on Clinical Trials Registry, India [CTRI/2022/07/044190] on 20 July, 2022; URL: <a href="https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzA4MTA=&amp;Enc=&amp;userName=">https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzA4MTA=&amp;Enc=&amp;userName=</a>.</p>

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Safety and Effectiveness of a Fixed-Dose Combination of Cephalexin Extended Release and Clavulanate Potassium in Bacterial Sore Throat and Uncomplicated Skin and Soft-Tissue Infections: A Multicentre, Open-Label, Phase IV Study in India

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  • 发表日期：

    2026年1月23日

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  • Sunil Panda,
  • Shrinivas Chavan,
  • Sumit Agarwal,
  • Neha Sharma,
  • Parth Bipinkumar,
  • Harshal Chaudhari,
  • Dipak Solanki,
  • Mandodari Rajurkar,
  • Sapan Behera,
  • Supriya Sonowal,
  • Dipak Patil,
  • Pravin Ghadge,
  • Lalit Lakhwani,
  • Suyog Mehta,
  • Sadhna Joglekar

摘要

Background and Objectives

Respiratory tract infections and skin and soft-tissue infections are some of the most common causes of outpatient visits. Upper respiratory tract infections (URTIs) are the most common type of infection globally, as well as in India. In 2019, its global incidence was 17.2 billion. Additionally, the Infectious Diseases Society of America 2012 guidelines for the management of Group A streptococcal pharyngitis strongly recommend penicillin or amoxicillin for individuals without penicillin allergy. Therefore, we conducted this study to assess the real-world safety and efficacy of a fixed-dose combination of cephalexin extended release and clavulanate potassium (cephalexin CV) in patients with URTIs and uncomplicated skin and soft-tissue infections (uSSTIs).

Methods

In this phase IV, multicentre, open-label, single-arm study, patients with URTIs and uSSTIs were prescribed cephalexin CV (375 mg + 125 mg or 750 mg + 125 mg for severe infection) orally twice daily for 10 days. Patients were assessed for adverse events (AEs), clinical success defined as a clinical cure or clinical improvement, and microbiological success defined as a microbiological outcome of documented eradication or presumed eradication at the end of the study.

Results

A total of 230 patients were enrolled, 115 patients each with URTIs and uSSTIs. Only eight AEs were reported; seven were treatment-emergent AEs. In the URTI group, 1/115 (0.9%) patients reported one treatment-emergent AE and in the uSSTI group, 6/115 (5.2%) patients reported six treatment-emergent AEs. The most commonly reported treatment-emergent AE was diarrhoea. Three events of diarrhoea were related to the treatment (one in the URTI group and two in the uSSTI group). All AEs were of mild intensity and no serious AEs were reported. All patients with URTIs and 113 (98.3%) patients with uSSTIs showed clinical success; 16 (100%) patients with URTIs and 59 (96.7%) patients with uSSTIs showed microbiological success.

Conclusions

In this real-world study, the fixed-dose combination of cephalexin CV was safe, well tolerated and efficacious in terms of clinical and microbiological success for the treatment of URTIs and uSSTIs. In the current era of antimicrobial resistance, the fixed-dose combination of cephalexin CV can be an alternative therapeutic option.

Clinical Trial Registration

This study was prospectively registered on Clinical Trials Registry, India [CTRI/2022/07/044190] on 20 July, 2022; URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzA4MTA=&Enc=&userName=.