Primary prophylaxis with ciprofloxacin improves survival and reduces bacterial infections in patients with cirrhosis and ascites
| ISRCTN | ISRCTN25761503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25761503 |
| Secondary identifying numbers | 01/3045 |
- Submission date
- 19/01/2007
- Registration date
- 09/02/2007
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Ruben Terg
Scientific
Scientific
Caseros 2061
Buenos Aires
1264
Argentina
Study information
| Study design | Multicentre, randomised, double blind, placebo-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Primary prophylaxis with ciprofloxacin improves survival and reduces bacterial infections in patients with cirrhosis and ascites |
| Study acronym | SBP - Spontaneous Bacterial Peritonitis |
| Study hypothesis | The aim of the present study was to assess the efficacy of long-term administration of ciprofloxacin for primary prophylaxis of Spontaneous Bacterial Peritonitis (SBP) in patients with cirrhosis and low protein concentration in ascitic fluid. |
| Ethics approval(s) | The protocol was approved by local ethic committees (ethics committee of Hospital Bonorino Udaondo and Hospital Alejandro Posadas) on the 6th March 2000. |
| Condition | Cirrhotic patients with ascites |
| Intervention | Ciprofloxacin 500 mg a day or placebo, oral, during 12 months for intervention group and the control group. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ciprofloxacin |
| Primary outcome measure | To assess the efficacy of long-term administration of ciprofloxacin for primary prophylaxis of SBP in patients with cirrhosis and low protein concentration in ascitic fluid. |
| Secondary outcome measures | To assess the efficacy of long-term administration of ciprofloxacin for primary prophylaxis of other infections and mortality. |
| Overall study start date | 01/03/2000 |
| Overall study end date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 100 patients (50 in ciprofloxacin group and 50 in placebo group) |
| Total final enrolment | 100 |
| Participant inclusion criteria | Diagnosis of cirrhosis was based in clinical, biochemical, ultrasonographic and histological criteria. Inclusion criteria were: 1. Aged more than 18 and less than 80 years 2. Total protein in ascitic fluid less than 1.5 g/dl 3. Ability to give written informed consent |
| Participant exclusion criteria | 1. A previous episode of SBP 2. Antibiotics in the previous 30 days 3. Pregnancy 4. Active gastrointestinal bleeding 5. Encephalopathy more than grade two 6. Hepatocarcinoma or other malignancies 7. Allergy to quinolones 8. Serum creatinine more than 3 mg/dl 9. Bacterial infection |
| Recruitment start date | 01/03/2000 |
| Recruitment end date | 01/12/2005 |
Locations
Countries of recruitment
- Argentina
Study participating centre
Caseros 2061
Buenos Aires
1264
Argentina
1264
Argentina
Sponsor information
The Health Council of Investigation of the Government of Buenos Aires (Argentina)
Government
Government
Medrano 350
Piso 2
Buenos Aires
1179
Argentina
| Website | http://www.buenosaires.gov.ar/area/salud/cons_investigación |
|---|
Funders
Funder type
Government
The Health Council of Investigation of the Government of Buenos Aires (Argentina) (ref: 01/3045)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
