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Trial record 10 of 764 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study

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ClinicalTrials.gov Identifier: NCT00985608
Recruitment Status : Unknown
Verified September 2009 by Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : September 28, 2009
Last Update Posted : January 26, 2010
Sponsor:
Information provided by:
Catholic University of the Sacred Heart

Tracking Information
First Submitted Date  ICMJE September 25, 2009
First Posted Date  ICMJE September 28, 2009
Last Update Posted Date January 26, 2010
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
To evaluate the usefulness of NAC as pre-treatment attempt associated with a culture-guided antibiotic therapy as rescue therapy after multi-attempts antibiotic failure [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00985608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study
Official Title  ICMJE Efficacy of Acetilcysteine in 'Rescue' Therapy for Helicobacter Pylori Infection. Pilot Study
Brief Summary

H pylori gastric infection is one of the most prevalent infectious diseases worldwide. The discovery that most upper gastrointestinal diseases are related to H pylori infection and therefore can be treated with antibiotics is an important medical advance. Currently, a first-line triple therapy based on proton pump inhibitor (PPI) or ranitidine bismuth citrate (RBC) plus two antibiotics (clarithromycin and amoxicillin or nitroimidazole) is recommended by all consensus conferences and guidelines. Even with the correct use of this drug combination, infection can not be eradicated in up to 23% of patients. Therefore, several second line therapies have been recommended. A 7 d quadruple therapy based on PPI, bismuth, tetracycline and metronidazole is the more frequently accepted. However, with second-line therapy, bacterial eradication may fail in up to 40% of cases. When H pylori eradication is strictly indicated the choice of further treatment is controversial. When available, endoscopy with culture and consequent antibiotic susceptibility testing remains the most appropriate option for patients with two eradication failures to avoid a widespread use of expensive antibiotics. The use of these drugs may also induce severe side-effects and development of H pylori resistant strains.

Resistant strains of Helicobacter pylori can display a dense biofilm with mucus and microorganisms in a coccoid shape on the mucosal surface of stomach that may have a role in determining the resistance to the antibiotic therapies. Possibly, N-acetil-cysteine (NAC) may dissolve biofilm architecture and help to eradicate resistant strains of H pylori.

Detailed Description To evaluate the usefulness of NAC as pre-treatment attempt associated with a culture-guided antibiotic therapy as rescue therapy after multi-attempts antibiotic failure, in the first phase of the study, the effect of NAC on biofilm formation and on its demolition will be tested in vitro by adding NAC in cultured H pylori isolates from a limited number of patients (n10) with an history of at least 4 failed eradicating attempts. Two biopsy samples of gastric mucosa will be obtained during endoscopy for microbiological purpose. Specimens will be used for H pylori culture. In specimens from 5 patients, H pylori will be cultured together with NAC 2 mg, while in the other 5 cases, H pylori culture will be carried out without NAC. In these latter, after the biofilm formation, H pylori isolates will be faced with different doses of NAC (2 mg, 10 mg, and 20 mg) to observe the behavior of biofilm. In the second phase of the study, 40 patients, after at least four unsuccessful H pylori eradication attempts, will be consecutively recruited. During endoscopy, in each patient, at least 4 mucosal biopsies will be obtained from the gastric body. Two of these biopsies will be used for biofilm study at the scanning electron microscopy (SEM). The remaining biopsies will be used for H pylori culture. From culture, the in vitro antibiotic susceptibility testing together with genetic analysis of H pylori isolates will be performed. On the basis of antibiotic susceptibility testing alone, patients will then randomly assigned to receiving two different eradication schedules: Group A, patients receiving NCA 600 mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics against H pylori; group B (control), patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics. Sensitive antibiotics will be always chosen on the basis of the more favorable minimum inhibiting concentration value. all patients will have a diary to record the side effects and symptoms during therapy. Compliance will measured by counting the tablets returned after the 7-day treatment. Patients will take a control C13 urea breath test at least two months after the end of therapy. They will be also invited to repeat endoscopic examination for monitoring biofilm persistence or absence. Finally, results obtained with the two treatment arms will be compared and evaluated also on the light of genetic analyses of H pylori isolates.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Helicobacter Pylori Infection
Intervention  ICMJE
  • Drug: Group A: NCA 600 mg+antibiotics
    NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
  • Drug: Group B: antibiotic treatment (control)
    patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
Study Arms  ICMJE
  • Active Comparator: Group B: antibiotic treatment (control)
    patients receiving solely a culture-guided one-week antibiotic treatment including a PPI plus two antibiotics
    Intervention: Drug: Group B: antibiotic treatment (control)
  • Active Comparator: Group A: NCA 600mg +antibiotics
    NCA 600mg once a day for a week and subsequently a culture-guided one-week regimen including a PPI plus two antibiotics
    Intervention: Drug: Group A: NCA 600 mg+antibiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 25, 2010)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2009)
20
Estimated Study Completion Date  ICMJE September 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Both genders
  • Age > 18 years
  • Persistent infection from Helicobacter pylori, at gastroscopy or 13C urea breath test, after at least two antibiotic unsuccessful eradication attempts

Exclusion Criteria:

  • Verified allergies to the acetylcysteine or to the antibiotics to cure Helicobacter pylori
  • Pregnancy, nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985608
Other Study ID Numbers  ICMJE 253/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giovanni Cammarota, MD, Catholic University of the Sacred Heart-Institute of Internal Medicine
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Giovanni Cammarota, MD Catholic University, Institute of Internal Medicine
PRS Account Catholic University of the Sacred Heart
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP