CEFACLOR VERSUS CLARITROMYCIN IN ACUTE BRONCHITIS

Not Applicable

• Conditions: -J20; J20

• Registration Number: PER-053-00
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-10-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Diagnosis of acute bronchitis and having a chest x-ray at the time of assignment to a treatment to exclude pneumonia.
2. Over 18 years of age or, with a minimum weight of 37 kg. Women of childbearing age (between 18 and 45 years old) with negative pregnancy test in blood and with commitment to use a reliable method of birth control during the study period.
3. Patients, who in the opinion of the investigator are able to comply with the instructions.
4. Sign an informed consent document approved by the Ethics Committee.

Exclusion Criteria

5. Have received a systemic antimicrobial therapy within 7 days prior to the assignment to a therapy.
6. Anticipated requirement of systemic antibiotics other than the study antibiotic after the pre-therapy evaluation and before the
post-therapy evaluation.
7. Pregnant women and women who are breastfeeding.
8. Inability of the individual to swallow tablets
9. History of renal and / or hepatic insufficiency.
10. Concomitant infection (tuberculosis or suspected pneumonia) that in the opinion of the investigator may alter the evaluation of the response to a therapy.
11. Have received a research agent within the last 30 days.
12. Known immediate hypersensitivity to cephalosporin or penicillin.
13. Patients with cystic fibrosis.
14. Patients, who suffer or have suffered in the past six months of symptomatic infection of the Epstein-Barr virus.
15. Patients, who may require a hospitalization during their participation in the study.
16. Patient´s inability to return to the follow-up visit.
17. Patients, who have previously completed or who have withdrawn from this study.
18. Researchers and their immediate families. The immediate family is defined as the researcher´s wife, parents, children or siblings.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The efficacy is fulfilled with the following:<br>The severity (using a 0-3 scale) of the signs and symptoms of the infection (cough, dyspnea, sputum volume, sputum purulence, tachypnea, panting, fever, chest pain).<br>The symptomatic response is also evaluated in the post-therapeutic view, before the patient discontinues therapy prematurely.<br>Measure:efficacy<br>Timepoints:The therapeutic effects will be compared in reduction of the clinical signs in the visit of the pre-therapy and in the post-therapy.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:The safety of each therapy will be determined by the registry of adverse effects for each arm of the therapy.<br>Measure:Safety<br>Timepoints:Adverse events will be collected after the patient has been assigned to therapy. The Lilly Clinical Research Doctor will monitor the safety data throughout the course of the study.<br>;<br>Outcome name:The tolerance of each therapy will be determined by recording the gastrointestinal adverse effects requested for each arm in each of the study visits.<br>Measure:Security<br>Timepoints:The safety assessment will be performed by recording adverse clinical events and gastrointestinal events (Gl) produced during the participation of the patient in the study.<br>