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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Providencia; Centro de Investigación de Enfermedades Respiratorias | Lima | 15088 | Peru | |||
| Clinica de Especialidades Medicas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30832720 | Derived | 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. |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D006140 | Guaifenesin |
| D013420 | Sulfamethoxazole |
| D014295 | Trimethoprim |
| ID | Term |
|---|---|
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 |
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| 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. |
|
| 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. |
|
| 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) |
| Percentage of Participants With Balsamic Bactrim Treatment Reintroduction After Discontinuation | 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 | 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) | From Day 1 up to end of observation (up to 10 days) |
| Lima |
| Lima 41 |
| Peru |
| Clinica San Borja; Instituto de Enfermedades Respiratorias EFEH | Lima | Lima 41 | Peru |
| Centro de Investigaciones Medicas/Hospital Maria Auxiliadora | San Juán de Miraflores | 15801 | Peru |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |