ACTRN12613001068752招募中未知
A multi-centre open label randomised non-inferiority study to compare the efficacy of antibiotics versus watchful waiting for Acute Otitis Media without perforation in low-risk urban Aboriginal and Torres Strait Islander children
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 495
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Months 至 16 Years（—）
- 性别
- All
入选标准
- •1. Aboriginal and/or Torres Strait Islander child (as defined by the health service they are attending)
- •2. Aged 18 months to 16 years (inclusive)
- •3. First enrolment into the study
- •4. Current acute otitis media without perforation diagnosed by a medical practitioner due to fluid in the middle ear on tympanometry (Type B tympanogram) and at least one of the following:
- •bulging of the eardrum on otoscopy,
排除标准
- •The child has been on any antibiotic in the previous 4 days
- •At high risk of chronic suppurative otitis media (CSOM), as defined by residing in geographic area known to have prevalence of CSOM >4%
- •A grommet in situ, or current or past history of tympanic membrane perforation
- •A condition which increases the risk of complications (e.g.,
- •immunosuppression, genetic or chromosomal abnormality, cleft palate or mid-face abnormalities such as seen in Down Syndrome)
- •Systemic features necessitating antibiotic treatment (e.g.,
- •septicaemia, meningitis, pneumonia, or urinary tract infection)
研究者
相似试验
招募中
3 期
SIOP RANDOMET 20172023-508926-91-00GPOH gGmbH307
进行中（未招募）
1 期
SIOP RANDOMET 2017Stage IV childhood renal tumour with pulmonary +/- non-pulmonarymetastasisMedDRA version: 20.0Level: PTClassification code: 10029145Term: Nephroblastoma Class: 100000004864CTIS2023-508926-91-00GPOH gGmbH363
进行中（未招募）
1 期
Randomized phase 3 clinical trial for patients with metastasized childhood renal tumourStage IV childhood renal tumoursEUCTR2018-000533-13-BEGesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH406
招募中
3 期
Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, standard arm) with upfront Vincristine, Carboplatin and Etoposide (VCE, experimental arm)Metastatic childhood renal tumourC64Malignant neoplasm of kidney, except renal pelvisDRKS00021160GPOH gGmbH406
进行中（未招募）
1 期
Randomized phase 3 clinical trial for patients with metastasized childhood renal tumourStage IV childhood renal tumoursEUCTR2018-000533-13-ATGesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH406