CirrhosisPhase 4NCT00760032
Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients
A Phase 4 study testing Ciprofloxacin in people with Cirrhosis and Ascites, run by Florencia Vargas-Vorackova at 1 site in Mexico.
Trial summary
The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Ascites, Infections
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhosis
- Ascites
- No history of spontaneous bacterial peritonitis and/or < 1 g of protein in ascites
- No antibiotic use in previous 6 weeks
- Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
- Absence of GI bleeding or encephalopathy
- Signature of informed consent
Who cannot join
- Ciprofloxacin contraindication
- Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
- > 13 Child-Pugh points
- Inability to attend to regular visits
- Current alcohol intake
- Terminal disease with < 24 week expected survival
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
México, D.f., 14000
About this study
Official title: Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients
The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.
- Conditions
- Cirrhosis, Ascites, Infections
- Being tested
- Ciprofloxacin, Placebo
- Keywords
- Cirrhosis, Ascites, Lipopolysaccharide binding protein, Infections, Cytokines, Ciprofloxacin
- Medical subject headings
- Fibrosis, Ascites, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Also called Ciproflox
Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.
PlaceboDrug
Placebo capsules, one capsule per day during four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Ciprofloxacin Receives: Drug: Ciprofloxacin |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipopolysaccharide binding protein plasma levels
Measured: 24 weeks
Secondary outcomes (2)
Severe infection
Measured: 24 weeks
Pro- and anti-inflammatory cytokine secretion by PBMN cells
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
Why it stopped: was not possible to measure LBP levels because we cannot found the kit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florencia Vargas-Vorackova
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratorios Senosiain, S.A. de C.V.
- Responsible party
- Sponsor-investigator, Florencia Vargas-Vorackova, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Investigators
- Florencia Vargas-Vorackova, M.D., Ph.D., Principal investigator, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760032
- Sponsor's protocol ID
- GAS-149-07-09-1
- Other IDs
- REF. 1612
- Status last verified
- Dec 2012
- First submitted
- 24 Sep 2008
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT00760032
- Acronym / sponsor ID
- GAS-149-07-09-1
- Conditions
- Cirrhosis, Ascites, Infections
- Keywords
- Cirrhosis, Ascites, Lipopolysaccharide binding protein, Infections, Cytokines, Ciprofloxacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: was not possible to measure LBP levels because we cannot found the kit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Florencia Vargas-VorackovaUniversity, hospital or other
- Collaborators
- Laboratorios Senosiain, S.A. de C.V.
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: CiprofloxacinCiprofloxacin |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cirrhosis
- Ascites
- No history of spontaneous bacterial peritonitis and/or < 1 g of protein in ascites
- No antibiotic use in previous 6 weeks
- Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis)
Key exclusion criteria (6 listed)
- Ciprofloxacin contraindication
- Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease
- > 13 Child-Pugh points
- Inability to attend to regular visits
- Current alcohol intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CiprofloxacinAlso: CiprofloxCiprofloxacin oral, 500 mg capsules, one capsule per day during four weeks. | Drug | Active |
| PlaceboPlacebo capsules, one capsule per day during four weeks. | Drug | Placebo |
Primary outcome
Lipopolysaccharide binding protein plasma levels
Time frame: 24 weeks
2 secondary outcomes
Severe infection
Time frame: 24 weeks
Pro- and anti-inflammatory cytokine secretion by PBMN cells
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Sponsor's Web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florencia Vargas-Vorackova, M.D., Ph.D. principal investigator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin in people with Cirrhosis and Ascites, run by Florencia Vargas-Vorackova at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipopolysaccharide binding protein plasma levels (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.