A Randomized, open label, prospective, two arm, comparative multicentric study to evaluate the efficacy and safety of fixed dose combination of cefpodoxime 200 mg + Clavulanic acid 125 mg (Cefchamp tablet) vs Cefpodoxime 200 mg in treatment of patients with lower respiratory tract infections - CEFCHAMP-LRTI

Abbott Healthcare Pvt Ltd0 个研究点目标入组 220 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male and Females aged 18 years and above.
•2.Patients with clinical signs and symptoms of lower respiratory tract infection.
•3.Normal Chest X-ray.
•4.Patients must give written informed consent after reading the Patient Information and Consent Form and having had the opportunity to discuss the study with the Investigator.
•5.Patient willing to follow up and comply with the Protocol requirements.

•1.Patients with Upper Respiratory Tract Infection (URTI).
•2.Patients with a known allergy to any of ingredients of investigational product and/or comparator product.
•3.Patients allergic to cephalosporin group of antibiotics.
•4.Patients with a history of allergic reactions to any penicillin.
•5.Patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with cefpodoxime and / or Clavulanic acid.
•6.Pregnant and lactating females.
•7.Patient not willing to participate in the trial or not in position to give the informed consent.
•8.Immunocompromized patients.

发起方