2025-523121-17-00招募中4 期
Multicenter clinical trial on the effectiveness and safety of outpatient treatment of acute uncomplicated diverticulitis without antibiotics versus antibiotic treatment. ADIANA Trial.
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia5 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 282
- 试验地点
- 5
研究概览
简要总结
To evaluate the effectiveness and safety of outpatient treatment without antibiotics compared to outpatient treatment with antibiotics in patients with uncomplicated acute diverticulitis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age with a clinical and radiological diagnosis of uncomplicated acute diverticulitis of the sigmoid colon or descending colon (left-sided AD).
- •Radiological diagnosis of acute uncomplicated diverticulitis by CT scan (modified Hinchey classification 0-Ia).
- •First episode or previous history of AD (both complicated and uncomplicated, and ≥6 months having elapsed since the last episode to the current clinic visit).
- •Signing of the informed consent form to participate in the study
排除标准
- •Age >70 years old
- •Patients who are candidates for hospitalization and/or intravenous antibiotic therapy (at diagnosis): Repeated vomiting or oral intolerance, need for intravenous fluid therapy and/or close monitoring, temperature >38°C, deterioration of general condition, and/or clinical suspicion of sepsis.
- •Significant or decompensated comorbidity (ASA classification IV).
- •Immunocompromised patients: Hematological causes, HIV with low CD4+ levels, immunosuppressive treatment, prolonged treatment with corticosteroids, chemotherapy, transplant or splenectomy patients, predisposing genetic disorders (severe combined immunodeficiency, etc.).
- •Oral or intravenous antibiotic therapy in the 2 weeks prior to the onset of symptoms, for another cause.
- •Inflammatory bowel disease (Crohn's disease, ulcerative colitis).
- •Lack of social support that makes outpatient treatment impossible.
研究组 & 干预措施
ciprofloxacino cinfa 500 mg comprimidos recubiertos EFG
Test
干预措施: ciprofloxacino cinfa 500 mg comprimidos recubiertos EFG (Drug)
amoxicilina/ácido clavulánico cinfa 875 mg/125 mg comprimidos recubiertos con película EFG
Test
干预措施: amoxicilina/ácido clavulánico cinfa 875 mg/125 mg comprimidos recubiertos con película EFG (Drug)
cefuroxima cinfa 250 mg comprimidos recubiertos con película EFG
Test
干预措施: cefuroxima cinfa 250 mg comprimidos recubiertos con película EFG (Drug)
MEIACT 200 mg comprimidos recubiertos con película
Test
干预措施: MEIACT 200 mg comprimidos recubiertos con película (Drug)
ciprofloxacino cinfa 750 mg comprimidos recubiertos EFG
Test
干预措施: ciprofloxacino cinfa 750 mg comprimidos recubiertos EFG (Drug)
Metronidazol Normon 250 mg comprimidos EFG
Test
干预措施: Metronidazol Normon 250 mg comprimidos EFG (Drug)
研究者
María Muñoz García
Scientific
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
研究点 (5)
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