CTRI/2023/08/056267尚未招募4 期
A Prospective, Multi-center, Single-arm, Phase IV Study to Assess the Safety & Efficacy of Amoxycillin and Potassium Clavulanate Oral Suspension in Children With Upper Respiratory Tract Infection (URTI) or Lower Respiratory Tract Infection (LRTI)
Sun Pharmaceuticals Industries Limited SPIL12 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2023年8月18日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 12
- 主要终点
- Proportion of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This is a Phase 4, single-arm, multicenter study. The study will be conducted at approximately 10 to 15 number of centers in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval. After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment. After confirming the eligibility, patients will be administered Test product, i.e., Amoxycillin and Potassium Clavulanate Oral Suspension (600 mg + 42.9 mg/5 ml) twice daily (every 12 hours) for 5-10 days depending on diagnosis and severity of symptoms. After 5 to 10 days of treatment, end of study visit will be conducted on Day 5 to 10 (+4 days) based on the last dose of test product administered. During the study, assessments will be performed as mentioned in Schedule of Assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children of either gender, aged between ≥3 months and <18 years, and weight less than 40 kg 2.Confirmed clinical diagnosis of URTI [acute otitis media (AOM) OR tonsillo-pharyngitis OR acute bacterial sinusitis] OR LRTI [lobar pneumonia and/or bronchopneumonia] for which patient require treatment with Amoxycillin and Potassium Clavulanate Oral Suspension based on Investigator’s opinion 3.Parent/Legal guardian is willing to give written informed consent and patient willing to give oral assent if aged 7 to <12 years and written assent if aged ≥12 years 4.Patient able to swallow study medications and follow study protocol 5.For females of childbearing potential, parents should confirm that the patient is not pregnant and investigator should also confirm the same.
- •In case of any doubt, investigator should conduct urine pregnancy test (UPT).
- •Note: However, if pregnancy is detected any time after enrolment, then parents should inform the investigator and the patient should be withdrawn from the study.
排除标准
- •1.Patients weighing >40 kg 2.Suspicion of non-infectious or viral aetiology 3.Patients with complicated URTI/ LRTI requiring intravenous antibiotics or hospitalisation 4.Patient with history of prior lung conditions 5.Patient with history of pulmonary tuberculosis 6.Patient having history of hypersensitivity to penicillin or any beta-lactam antibiotics 7.Patient having history of amoxycillin-clavulanate associated cholestatic jaundice/ hepatic impairment 8.Patient having history of bleeding disorder or currently on anticoagulants 9.Patient with history of phenylketonuria 10.Patient undergoing haemodialysis 11.Patients on probenecid or allopurinol 12.Patients with any clinically significant condition which in the opinion of Investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
- •13.Patients with high risk of carrying amoxycillin-resistant organisms [received amoxycillin or penicillin or other beta-lactam antimicrobials in the last 30 days, OR history of methicillin-resistant Staphylococcus aureus (MRSA) infection] 14.Patient using other antimicrobials in last 30 days 15.Patient with history or current signs and symptoms suggestive of renal impairment (e.g., puffiness of face, pedal oedema, ascites, abnormal urine output etc.) 16.Patient with history or current signs and symptoms suggestive of hepatic impairment (e.g., icterus, anemia, ascites, pain in abdomen, abnormal internal bleeding etc.) 17.Patient with history or current serious underlying disease like but not limited to epilepsy, congenital disorder, metabolic disorder, cardiovascular disease, hepatic disorder, renal disorder, intestinal perforation or obstruction, congenital gastro-intestinal malformation, genito-urinary disorder etc.
- •18.Concomitant infection which would preclude evaluation of the response of his/her URTI/ LRTI to the study intervention.
- •19.Patient with history of Human Immunodeficiency Virus (HIV) and / or Hepatitis B and/ or Hepatitis C 20.Patients with other disease or medication leading to immune-compromised condition 21.Patient with history of significant active peptic ulceration 22.Patient with history of cancer or undergoing cancer chemo or radiotherapy 23.Patient who have participated in another Investigational study within the 3 months prior to enrolment in this study 24.Patient with known alcohol or other substance abuse within last one year 25.Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees of Sponsor or the Investigator.
结局指标
主要结局
Proportion of participants with treatment-emergent adverse events (TEAEs)
时间窗: Throughout the study period
次要结局
- Proportion of participants with serious adverse events (SAEs)(Throughout the study period)
- Proportion of participants with diarrhoea(Throughout the study period)
- Proportion of patients with clinical improvement(End of study)
- Proportion of patients with clinical failure(End of study)
- Proportion of patients with clinical relapse(End of study)
- Proportion of patients achieving clinical cure(End of study)
- Time to symptom resolution (based on patient report)(Day 1 to End of study)
研究者
研究点 (12)
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