Clinical trial • Not applicable • Gastroenterology
CEFUROXIME for Diverticular disease | Acute uncomplicated diverticulitis
Not applicable trial of CEFUROXIME for Diverticular disease | Acute uncomplicated diverticulitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Diverticular disease | Acute uncomplicated diverticulitis
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 23-12-2025
- First CTIS Authorization Date
- 30-04-2026
Trial design
Outpatient treatment without antibiotics versus outpatient treatment with antibiotics; antibiotic products listed in Part I include: cefuroxima 250 mg, cefditoren (MEIACT) 200 mg, ciprofloxacin 500 mg and 750 mg, amoxicillin/clavulanic acid 875 mg/125 mg, metronidazole 250 mg. Doses/schedules for each arm are not specified in the provided record.-controlled Not applicable trial across 5 sites in Spain.
- Comparator
- Outpatient treatment without antibiotics versus outpatient treatment with antibiotics; antibiotic products listed in Part I include: cefuroxima 250 mg, cefditoren (MEIACT) 200 mg, ciprofloxacin 500 mg and 750 mg, amoxicillin/clavulanic acid 875 mg/125 mg, metronidazole 250 mg. Doses/schedules for each arm are not specified in the provided record.
- Target Sample Size
- 282
Eligibility
Recruits 282 Vulnerable population not selected; participants must be over 18 and sign informed consent; no vulnerable groups or assent procedures are specified..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population not selected; participants must be over 18 and sign informed consent; no vulnerable groups or assent procedures are specified.
Inclusion criteria
- {"criterion_text":"- 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).\n- Radiological diagnosis of acute uncomplicated diverticulitis by CT scan (modified Hinchey classification 0-Ia).\n- 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).\n- Signing of the informed consent form to participate in the study"}
Exclusion criteria
- {"criterion_text":"- Age >70 years old\n- 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.\n- Significant or decompensated comorbidity (ASA classification IV).\n- 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.).\n- Oral or intravenous antibiotic therapy in the 2 weeks prior to the onset of symptoms, for another cause.\n- Pregnancy\n- Inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n- Lack of social support that makes outpatient treatment impossible."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Therapeutic failure rate (early, within ≤48 hours, and at one month) for both treatments (with and without antibiotics).","definition_or_measurement_approach":"Therapeutic failure measured early (≤48 hours) and at one month for both treatment arms (with antibiotics vs without antibiotics)."}
Secondary endpoints
- {"endpoint_text":"- Results in terms of recurrence (number, type, and time to onset).","definition_or_measurement_approach":"Recurrence characterised by number, type and time to onset."}
- {"endpoint_text":"- Time (days) until clinical recovery and return to daily social and work life.","definition_or_measurement_approach":"Measured in days from baseline until clinical recovery and return to normal social/work activities."}
- {"endpoint_text":"- Risk factors for the development of diverticulitis and prognostic factors predictive of therapeutic failure and unfavorable progression to complicated acute diverticulitis, in general and according to treatment group","definition_or_measurement_approach":"Assessment of demographic, clinical and complementary test findings as predictors of therapeutic failure and progression to complicated disease; analysed overall and by treatment group."}
- {"endpoint_text":"- Quality of life and level of satisfaction with the care received in both groups","definition_or_measurement_approach":"Patient-reported quality of life and satisfaction measures comparing the two groups."}
Recruitment
- Planned Sample Size
- 282
- Recruitment Window Months
- 24
- Consent Approach
- Participants must sign the informed consent form to participate in the study (document L1_SIS and ICF listed). Only adults (>18) are eligible; informed consent obtained from participant. Study documentation/translations available in Spanish (protocol/public title translations present). No assent procedures or additional languages specified.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 282
Spain
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 100
- Number Of Sites
- 5
- Number Of Participants
- 282
Sites
- Site Name
- Hospital General Universitario Morales Meseguer
- Department Name
- general surgery and digestive system
- Principal Investigator Name
- Monica Mengual Ballester
- Principal Investigator Email
- xxxxx@gmail.com
- Contact Person Name
- Monica Mengual Ballester
- Contact Person Email
- xxxxx@gmail.com
- Site Name
- Hospital Universitario De Getafe
- Department Name
- general surgery and digestive system
- Principal Investigator Name
- Alba Manuel Vázquez
- Principal Investigator Email
- xxxx@gmail.com
- Contact Person Name
- Alba Manuel Vázquez
- Contact Person Email
- xxxx@gmail.com
- Site Name
- Hospital General Universitario De Elche
- Department Name
- general surgery and digestive system
- Principal Investigator Name
- Luís Sánchez Guillén
- Principal Investigator Email
- xxxx@gmail.com
- Contact Person Name
- Luís Sánchez Guillén
- Contact Person Email
- xxxx@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- general surgery and digestive system
- Principal Investigator Name
- Quiteria Francisca Hernández Agüera
- Principal Investigator Email
- xxxx@gmail.com
- Contact Person Name
- Quiteria Francisca Hernández Agüera
- Contact Person Email
- xxxx@gmail.com
- Site Name
- Hospital Obispo Polanco
- Department Name
- General and Digestive Surgery
- Principal Investigator Name
- José Francisco Noguera Aguilar
- Principal Investigator Email
- xxxx@gmail.com
- Contact Person Name
- José Francisco Noguera Aguilar
- Contact Person Email
- xxxx@gmail.com
Sponsor
Primary sponsor
- Full Name
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- cefuroxima cinfa 250 mg comprimidos recubiertos con película EFG
- Active Substance
- CEFUROXIME
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 72258)
- Starting Dose
- 250 mg
- Maximum Dose
- 500 mg/day
- Investigational Product Name
- MEIACT 200 mg comprimidos recubiertos con película
- Active Substance
- CEFDITOREN PIVOXIL
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 65.943)
- Starting Dose
- 200 mg
- Maximum Dose
- 400 mg/day
- Investigational Product Name
- ciprofloxacino cinfa 500 mg comprimidos recubiertos EFG
- Active Substance
- CIPROFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 62.765)
- Starting Dose
- 500 mg
- Maximum Dose
- 1000 mg/day
- Investigational Product Name
- amoxicilina/ácido clavulánico cinfa 875 mg/125 mg comprimidos recubiertos con película EFG
- Active Substance
- AMOXICILLIN, CLAVULANIC ACID
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 67.892)
- Starting Dose
- 875 mg / 125 mg
- Maximum Dose
- 2625 mg/day
- Investigational Product Name
- ciprofloxacino cinfa 750 mg comprimidos recubiertos EFG
- Active Substance
- CIPROFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 62.766)
- Starting Dose
- 750 mg
- Maximum Dose
- 2250 mg/day
- Investigational Product Name
- Metronidazol Normon 250 mg comprimidos EFG
- Active Substance
- METRONIDAZOLE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 62.223)
- Starting Dose
- 250 mg
- Maximum Dose
- 500 mg/day
- Combination Treatment
- Yes
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