Clinical trial NCT02902640: A Non-Interventional Safety Study of Balsamic Bactrim
Official title: A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Adult Patients With Acute Bronchitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants with Adverse Events Related to Balsamic Bactrim as Assessed by the Treating Physician
timeFrame: From Day 1 up to end of observation (up to 10 days)
Secondary outcomes:
measure: Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)
timeFrame: From Day 1 up to end of observation (up to 10 days)
measure: Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change
timeFrame: From Day 1 up to end of observation (up to 10 days)
measure: Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration
timeFrame: From Day 1 up to end of observation (up to 10 days)
measure: Percentage of Participants With Balsamic Bactrim Dose Interruption
timeFrame: From Day 1 up to end of observation (up to 10 days)
measure: Percentage of Participants With Balsamic Bactrim Treatment Discontinuation
timeFrame: From Day 1 up to end of observation (up to 10 days)
measure: Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation
timeFrame: From Day 1 up to end of observation (up to 10 days)
measure: Percentage of Participants With Compliance to Balsamic Bactrim Treatment According to Local Label, as Assessed by Treating Physician
timeFrame: From Day 1 up to end of observation (up to 10 days)
measure: Percentage of Participants With Predisposing Factors (Categories) for Safety (No specific pre-defined factors, these will be decided based on observations during study)
timeFrame: From Day 1 up to end of observation (up to 10 days)
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias
city: Lima
country: Peru
facility: Clinica de Especialidades Medicas
city: Lima
country: Peru
facility: Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH
city: San Juan de Miraflores
country: Peru
facility: Centro de Investigaciones Medicas/Hospital Maria Auxiliadora
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Falcon M, Iberico C, Guerra F, Reyes I, Felix E, Flores M, de Los Rios J, Diaz ME, Casas A, Sanchez-Gambetta S, Carrasco R. A pilot study of safety of sulfamethoxazole, trimethoprim and guaifenesin in pediatric and adult patients with acute bronchitis. BMC Res Notes. 2019 Mar 4;12(1):119. doi: 10.1186/s13104-019-4150-2.