EUCTR2015-004874-13-Outside-EU/EEA进行中（未招募）1 期
An open label study to determine the pharmacokinetic profiles ofamoxicillin and clavulanate in adolescent patients weighing at least 40kgand no more than 16 years of age receiving AUGMENTIN™XR (amoxicillin2000mg/clavulanate 125mg) orally twice daily for 10 days.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient is a male or female who weighs at least 40 kg and is younger than 16 years
- •old (no older than their 16th birthday), inclusive.
- •2. Patients must be able to swallow AUGMENTIN XR tablets.
- •3. Patients with suspected acute bacterial sinusitis that may benefit from administration
- •of AUGMENTIN XR (in the opinion of the PI) and who are not considered to be at
- •risk of clinically significant adverse effects at the dose specified in the protocol.
- •4. Written informed consent by the patient’s parent or legal guardian and where
- •appropriate, written assent of the volunteer.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Definite or suspected personal history or family history of adverse reactions or
- •hypersensitivity or allergy to any penicillin or cephalosporin antibiotics. Also
- •history of reaction to multiple allergens (if considered clinically relevant by the
- •principal investigator).
- •2. Patients weighing less than 40 kg or older than 16 years of age (i.e., past their 16th
- •3. Patient is participating in another clinical trial or has received or anticipates
- •receiving an investigational drug, vaccine, or medical device (non-government)
- •within 30 days (or 5-half-lives, whichever is longer) prior to the first dose of study
- •medication or during the conduct of the study.
- •4. History or presence of gastrointestinal, hepatic or renal disease or other conditions
- •known to or that may interfere with the absorption, distribution, metabolism or
- •excretion of study medication.
- •5. Treatment with probenecid or allopurinol within 7 days of study entry.
- •6. A positive urine ß-hCG (human chorionic gonadotropin) test at screening (female
- •patients only) indicating pregnancy.
- •7. Female patients who are lactating (breast feeding).
- •8. Female patients who are unwilling to be abstinent until completion of the follow-up
- •9. History of diarrhea due to Clostridium difficile following treatment with antibiotics.
- •10. History of hypersensitivity or allergy to heparin or related preparations (if the
- •clinical research unit uses heparin to maintain intravenous cannula patency).
- •11. Patient is diagnosised with mononucleosis.
- •12. Estimated Glomerular Filtration Rate (GFR) <40 ml/min (refer to SRM for GFR
- •calculation formula).
- •13. Any condition, which in the opinion of the investigator, contraindicates the
- •administration of AUGMENTIN XR.
研究者
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