A Non-Interventional Safety Study of Balsamic Bactrim

NCT02902640 | Completed

• 1 other identifier: ML30018
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 4

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.

Conditions

Bronchitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Adverse Events Related to Balsamic Bactrim as Assessed by the Treating Physician

  From Day 1 up to end of observation (up to 10 days)

Secondary Outcomes (8)

• Percentage of Participants With Balsamic Bactrim Dose Change (Increase or Decrease)

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Balsamic Bactrim Dose Change by Reason for Change

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Change in Balsamic Bactrim Frequency of Administration

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Balsamic Bactrim Dose Interruption

  From Day 1 up to end of observation (up to 10 days)

• Percentage of Participants With Balsamic Bactrim Treatment Discontinuation

  From Day 1 up to end of observation (up to 10 days)

Study Arms (1)

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.

Drug: Guaifenesin; Drug: Sulfamethoxazole; Drug: Trimethoprim

Interventions

Guaifenesin DRUG

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.

Acute Bronchitis Participants

Sulfamethoxazole DRUG

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.

Acute Bronchitis Participants

Trimethoprim DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias

Lima, 15088, Peru

Location

Clinica de Especialidades Medicas

Lima, Lima 41, Peru

Location

Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH

Lima, Lima 41, Peru

Location

Centro de Investigaciones Medicas/Hospital Maria Auxiliadora

San Juán de Miraflores, 15801, Peru

Location

Related Publications (1)

• 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.

  PMID: 30832720 DERIVED

MeSH Terms

Conditions

Bronchitis

Interventions

Guaifenesin; Sulfamethoxazole; Trimethoprim

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Guaiacol; Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 16, 2016
• Study Start: November 15, 2016
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

PE (4)