Clinical trial NCT02879981: A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis
Official title: A Pilot, Multicentric and Observational Study of Safety of Sulfamethoxazole + Trimethoprim + Guaifenesin (Balsamic Bactrim) in Pediatric Patients With Acute Bronchitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric 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 pilot, multicentric and observational study will assess the safety of sulfamethoxazole + trimethoprim + guaifenesin (Balsamic Bactrim) in pediatric participants with acute bronchitis. Administration of treatment will be according to treating physician's recommendation under local labeling.


Eligibility criteria: Inclusion Criteria:

* Participants starting treatment with Bactrim Balsamic suspension
* Participants with a clinical diagnosis of acute bronchitis (cough with or without sputum production less than 30 days) according to the medical criteria

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 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 predefined 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: La Victoria
country: Peru
facility: Hospital Emergencias Pediatricas; Unidad de Investigación Pediátrica
city: Lima
country: Peru
facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional
city: San Isidro
country: Peru
facility: Clínica Anglo Americana-CENTRO DE INVESTIGACION PEDIATRIA CAA
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.