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
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The primary objective of the study is to evaluate the clinical cure rate of Cefditoren Pivoxil in acute respiratory tract infections
研究概览
简要总结
This clinical trial aims to evaluate theeffectiveness and safety of Cefditoren by assessing the percentage of subjects withacute respiratory infections who achieve clinical as well as bacteriologicalcure after a 10 day course. Clinical cure will be estimated for all enrolled subjects, bacteriological cure will assessed only for those subjects who have had a positive PCR for causative pathogens of hemophilus influenzae, streptococcus pneumoniae and moraxella catarrhalis at baseline.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •Written informed consent from the parent/guardian.
排除标准
- •Presence of active convulsions, child is unconscious or lethargic, not feeding or vomiting continuously.
- •Presence of chest in-drawing or stridor in a calm child
- •Presence of severe febrile disease complicated severe malnutrition.
- •Use of antibiotics for any other indication in the three weeks prior to enrollment
- •Evidence of any severe bacterial infection requiring parenteral antibiotics.
- •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.
- •History of known allergy to cefditoren pivoxil or any cephalosporins, penicillins.
- •Participating or planning to participate in another trial that might affect the current study
- •Any reason why, in the opinion of the investigator, the subject should not participate (e.g. not able to comply with study procedures).
结局指标
主要结局
The primary objective of the study is to evaluate the clinical cure rate of Cefditoren Pivoxil in acute respiratory tract infections
时间窗: Clinical Cure Rate: | Number and proportion of children with clinical cure at end of study visit (Day 11) defined as the disappearance of clinical signs and symptoms observed at baseline
次要结局
- The secondary objective of the study is to evaluate the clinical response rate and clinical failure rate of Cefditoren Pivoxil in acute respiratory tract infections and to evaluate the microbiological cure rate in those subjects who had a positive Polymerase Chain Reaction (PCR) for the causative pathogens (Streptococcus pneumoniae, moraxella catarrhalis and Haemophilus influenza) at baseline.(Clinical Response Rate:)