Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
282
Countries
1
Sites
5
Diverticular disease of the intestine,
To evaluate the effectiveness and safety of outpatient treatment without antibiotics compared to outpatient treatment with antibiotics in patients with uncomplicated acute diverticulitis.
Key facts
- Sponsor
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2026-04-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the effectiveness and safety of outpatient treatment without antibiotics compared to outpatient treatment with antibiotics in patients with uncomplicated acute diverticulitis.
Secondary objectives 3
- Evaluate and compare the results in terms of cure, recurrence, and cost-effectiveness between outpatient treatment with and without antibiotics.
- To study the risk factors for diverticulitis and the prognostic factors (demographic and clinical characteristics and findings in complementary tests) that predict therapeutic failure and progression to CAD, in general and in each treatment group (outpatient treatment with or without antibiotics).
- Assess the quality of life of these patients after the acute episode and their degree of satisfaction with the treatment received.
Conditions and MedDRA coding
Diverticular disease of the intestine,
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10013534 | Diverticular disease | 10017947 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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
Exclusion criteria 8
- 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.
- Pregnancy
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis).
- Lack of social support that makes outpatient treatment impossible.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Therapeutic failure rate (early, within ≤48 hours, and at one month) for both treatments (with and without antibiotics).
Secondary endpoints 4
- Results in terms of recurrence (number, type, and time to onset).
- Time (days) until clinical recovery and return to daily social and work life.
- 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
- Quality of life and level of satisfaction with the care received in both groups
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
cefuroxima cinfa 250 mg comprimidos recubiertos con película EFG
PRD11947964 · Product
- Active substance
- Cefuroxime
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 3500 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DC02 — -
- Marketing authorisation
- 72258
- MA holder
- LABORATORIOS CINFA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MEIACT 200 mg comprimidos recubiertos con película
PRD13177686 · Product
- Active substance
- Cefditoren Pivoxil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 2800 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DD16 — -
- Marketing authorisation
- 65.943
- MA holder
- MEIJI PHARMA SPAIN, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ciprofloxacino cinfa 500 mg comprimidos recubiertos EFG
PRD11927985 · Product
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- 62.765
- MA holder
- LABORATORIOS CINFA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
amoxicilina/ácido clavulánico cinfa 875 mg/125 mg comprimidos recubiertos con película EFG
PRD11943488 · Product
- Active substance
- Amoxicillin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2625 mg milligram(s)
- Max total dose
- 26250 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 67.892
- MA holder
- LABORATORIOS CINFA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ciprofloxacino cinfa 750 mg comprimidos recubiertos EFG
PRD542764 · Product
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2250 mg milligram(s)
- Max total dose
- 15750 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- 62.766
- MA holder
- LABORATORIOS CINFA S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Metronidazol Normon 250 mg comprimidos EFG
PRD11939207 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 3500 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- P01AB01 — METRONIDAZOLE
- Marketing authorisation
- 62.223
- MA holder
- LABORATORIOS NORMON, S.A.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Sponsor organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Address
- Carretera Madrid-Cartagena S/N, El Palmar El Palmar
- City
- Murcia
- Postcode
- 30120
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- María Muñoz García
Public contact point
- Organisation
- Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
- Contact name
- María Muñoz García
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 282 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital General Universitario Morales Meseguer
general surgery and digestive system, Avenida Del Marques De Los Velez S/n, 30008, Murcia
Hospital Universitario De Getafe
general surgery and digestive system, Carretera De Madrid Toledo Km 12,500, 28905, Getafe
Hospital General Universitario De Elche
general surgery and digestive system, Edificio 2, Camino De La Almazara 11, Elche
University Clinical Hospital Virgen De La Arrixaca
general surgery and digestive system, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Obispo Polanco
General and Digestive Surgery, Avenida De Ruiz Jarabo S/n, 44002, Teruel
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523121-17-00 | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC amoxicilina_acido clavulanico | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ciprofloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ciprofloxacino | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC MEIACT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Metronidazol | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN 2025-523121-17-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2025-523121-17-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-23 | Spain | Acceptable 2026-04-27
|
2026-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-05-19 | Spain | Acceptable | 2026-05-29 |