Effectiveness and Safety of Cefditoren Pivoxil in Childhood Acute Respiratory Tract Infection: A Prospective, Open Label, Single Arm, Unicentric, Phase IV (Post Marketing) Study In India

Zuventus Healthcare Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Children between the age of 1-5 years of both gender, with a clinical diagnosis of acute respiratory tract infection suggestive of a bacterial etiology in the opinion of the investigator and can be managed with oral antibiotic therapy
•2. Written informed consent from the parent/guardian

•1. Presence of active convulsions, child is unconscious or lethargic, not feeding or vomiting continuously.
•2. Presence of chest in-drawing or stridor in a calm child
•3. Presence of severe febrile disease complicated severe malnutrition.
•4. Use of antibiotics for any other indication in the three weeks prior to enrollment
•5. Evidence of any severe bacterial infection requiring parenteral antibiotics.
•6. Presence of any severe comorbidities such as haematological or oncological, immunodeficiency, congenital heart disease, neuromuscular impairment, development disorder, including downs syndrome, bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or other severe chronic lung diseases, which in the opinion of the Investigator renders the subject unfit to participate in the trial.
•7. History of known allergy to cefditoren pivoxil or any cephalosporins, penicillins.
•8. Participating or planning to participate in another trial that might affect the current study
•9. Any reason why, in the opinion of the investigator, the subject should not participate (e.g. not able to comply with study procedures)

发起方