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A Non-Interventional Safety Study of Balsamic Bactrim

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ClinicalTrials.gov Identifier: NCT02902640
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

September 13, 2016
September 16, 2016
November 7, 2017
November 15, 2016
July 31, 2017   (Final data collection date for primary outcome measure)
Percentage of Participants with Adverse Events Related to Balsamic Bactrim as Assessed by the Treating Physician [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
Percentage of participants with adverse events related to sulfamethoxazole + trimethoprim + guaifenesin (as assessed by the investigator) [ Time Frame: From baseline up to 6 months ]
Complete list of historical versions of study NCT02902640 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Percentage of Participants With Balsamic Bactrim Dose Interruption [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Percentage of Participants With Balsamic Bactrim Treatment Discontinuation [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific pre-defined factors, these will be decided based on observations during study) [ Time Frame: From Day 1 up to end of observation (up to 10 days) ]
  • Overall Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease) [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Dose Interruption [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Treatment Discontinuation [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician [ Time Frame: From baseline up to 3 months ]
  • Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific pre-defined factors, these will be decided based on observations during study) [ Time Frame: From baseline up to 3 months ]
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A Non-Interventional Safety Study of Balsamic Bactrim
A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult Patients With Acute Bronchitis
This is a pilot, observational and multicentric study of safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in adult participants with acute bronchitis. Adult participants with acute bronchitis eligible for treatment with Balsamic Bactrim will be enrolled. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Adult participants receiving treatment for acute bronchitis with Balsamic Bactrim according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling and who have no contraindication to Balsamic Bactrim as per the local label.
Bronchitis
  • Drug: Guaifenesin
    Guaifenesin will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
  • Drug: Sulfamethoxazole
    Sulfamethoxazole will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
  • Drug: Trimethoprim
    Trimethoprim will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
Acute Bronchitis Participants
Participants with acute bronchitis for whom the treating physician has decided to initiate treatment with Balsamic Bactrim, will be observed. Administration of Balsamic Bactrim will be according to physician's recommendation under local labeling. The study protocol does not enforce any treatment.
Interventions:
  • Drug: Guaifenesin
  • Drug: Sulfamethoxazole
  • Drug: Trimethoprim
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
50
July 31, 2017
July 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants starting treatment with Balsamic Bactrim as per treating physician's discretion
  • Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the treating physician's judgment

Exclusion Criteria:

  • Participants who have started treatment with another antibiotic at the time of the visit
  • Participants with no respiratory infections
  • Participants with mental disorders that do not permit the clinical evaluation of the participant according to the treating physician's criteria
  • Participants with severe hepatic parenchymal damage
  • Participants with severe renal failure making it difficult to monitor drug plasma concentration
  • Participants with hypersensitivity to any of Balsamic Bactrim active ingredients, excipients, and/or sulfas
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
 
NCT02902640
ML30018
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2017