An observational study in Tracheitis, Tracheobronchitis and Bronchitis, sponsored by Abbott. Completed at 135 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Abbott · Observational
This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.
Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.
209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.
This study's enrollment of 3,130 is above the median of 988 across 46 observational studies indexed under Bronchitis, Chronic.
Browse Bronchitis, Chronic studies →Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.
Compared within Bronchitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bronchitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
patients with: acute tracheitis, acute tracheobronchitis or acute bronchitis, acute exacerbation of chronic bronchitis, mild community-acquired pneumonia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Czech patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid®SR treatment 6 weeks prior to the next Klacid®SR dose or in intervals: 7-week - 3- month, 4- month - 12- month, 13- month - 24- month prior to the next Klacid®SR dose (next Klacid®SR dose = dose administered within this PMOS).
Disappearance or Significant Alleviation of Symptoms
Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response.
Time frame: Day 8 - 16
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)
Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).
Time frame: Day 0, Day 8 - 16
Body Temperature
Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
Time frame: Day 0, Day 8-16
Bacteriological Investigation (if Available)
The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.
Time frame: Day 0
Cough and Its Character
Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
Time frame: Day 0, Day 8-16
Dyspnea and Its Type
Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
Time frame: Day 0, Day 8-16
Auscultation
Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
Time frame: Day 0, Day 8-16
Chest X-ray in Case of Community-Acquired Pneumonia (CAP)
Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.
Time frame: Day 0
Study Drug Given as the First, Second or Third Antimicrobial Treatment
Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
Time frame: Day 0
Compliance
Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
Time frame: Day 8 - 16
Termination of Treatment Due to Noncompliance
Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
Time frame: Day 8 - 16
| Milestone | Klacid SR Treatment |
|---|---|
| Started | 3130 |
| Participants analyzed | 3128 |
| Completed | 3120 |
| Not completed | 10 |
| Withdrew: Patient noncompliance | 6 |
| Withdrew: Reason unknown | 1 |
| Withdrew: Adverse event | 3 |
Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response.
| Participants | Klacid SR Treatment |
|---|---|
| Disappearance or Significant Alleviation of Symptoms | 3109 |
Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).
| participants | Klacid SR Treatment |
|---|---|
| Initial Visit - Auscultation Normal | 956 |
| Initial Visit - Auscultation Abnormal | 2146 |
| Initial Visit - Findings Not Reported | 26 |
| Second Visit - Auscultation Normal | 2768 |
| Second Visit - Auscultation Abnormal | 247 |
| Second Visit - Findings Not Reported | 113 |
Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
| Participants | Klacid SR Treatment |
|---|---|
| Initial Visit - Temperature above 37 degrees C | 2252 |
| Initial Visit - Temperature not above 37 degrees C | 870 |
| Initial Visit - Temperature not reported | 6 |
| Second Visit - Temperature above 37 degrees C | 101 |
| Second Visit - Temperature not above 37 degrees C | 3013 |
| Second Visit - Temperature not reported | 14 |
The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.
| participants | Klacid SR Treatment |
|---|---|
| Haemophilus Influenzae | 48 |
| Streptococcus pneumoniae | 38 |
| Chlamydia pneumoniae | 34 |
| Mycoplasma pneumoniae | 14 |
| Haemophilus parainfluenzae | 13 |
| Klebsiella pneumoniae | 12 |
| Haemophilus species | 10 |
| Staphylococcus aureus | 5 |
| Branhamella catarrhalis | 5 |
Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
| Participants | Klacid SR Treatment |
|---|---|
| Initial Visit - Presence of cough | 2942 |
| a) Irritating cough | 1601 |
| b) Productive cough | 1177 |
| c) Both irritating and productive | 157 |
| d) Not Reported | 7 |
| Initial Visit -Cough not present | 186 |
| Second Visit -Presence of cough | 556 |
| a) Irritating cough. | 187 |
| b) Productive cough. | 351 |
| c) Both irritating and productive. | 16 |
| d) Not Reported. | 2 |
| Second Visit -Cough not present | 2572 |
Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
| Participants | Klacid SR Treatment |
|---|---|
| Initial Visit - Presence of dyspnea | 1091 |
| a) Exertional | 794 |
| b) Resting | 235 |
| c) Both exertional and resting | 60 |
| d) Type of dyspnea not reported | 2 |
| Initial Visit - Dyspnea not present | 2037 |
| Second Visit - Presence of dyspnea | 262 |
| a) Exertional- | 234 |
| b) Resting- | 17 |
| c) Both exertional and resting- | 9 |
| d) Type of dyspnea not reported- | 2 |
| Second Visit -Dyspnea not present | 2866 |
Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
| Participants | Klacid SR Treatment |
|---|---|
| Initial Visit - Abnormal Auscultaton findings | 2146 |
| a) Wheezing | 1577 |
| b) Crackles | 408 |
| c) Both wheezing and crackles | 145 |
| d) Not reported | 16 |
| Second Visit -Abnormal Auscultation findings | 247 |
| a) Wheezing- | 187 |
| b) Crackles- | 54 |
| c) Both wheezing and crackles- | 4 |
| d) Not reported- | 2 |
Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.
| Participants | Klacid SR Treatment |
|---|---|
| Findings indicative of pneumonia | 276 |
| Findings not indicative of pneumonia | 18 |
Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
| Participants | Klacid SR Treatment |
|---|---|
| Klacid SR as first antimicrobial treatment | 2910 |
| Klacid SR as second antimicrobial treatment | 216 |
| Klacid SR as third antimicrobial treatment | 2 |
Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
| Participants | Klacid SR Treatment |
|---|---|
| Compliance | 3122 |
Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
| Participants | Klacid SR Treatment |
|---|---|
| Termination of Treatment Due to Noncompliance | 6 |
Collected over Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Klacid SR Treatment | — | 2/3,128 (0.1%) | 7/3,128 (0.2%) |
| Event | Klacid SR Treatment |
|---|---|
| Tuberculosis pleuritisInfections and infestations | 1/3128 |
| Pulmonary tumorNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/3128 |
| Event | Klacid SR Treatment |
|---|---|
| DiarrheaGastrointestinal disorders | 3/3128 |
| Bad taste in mouthGastrointestinal disorders | 1/3128 |
| Loss of appetiteGeneral disorders | 1/3128 |
| Burning tongueGastrointestinal disorders | 1/3128 |
| Bitter taste in mouthGastrointestinal disorders | 1/3128 |
| DyspepsiaGastrointestinal disorders | 1/3128 |
| Gastrointestinal tract symptomsGastrointestinal disorders | 1/3128 |
| NauseaGastrointestinal disorders | 1/3128 |
| VomitingGastrointestinal disorders | 1/3128 |
| Age, Customized(participants) | Klacid SR Treatment |
|---|---|
| less than 18 years of age | 2 |
| 18 to 29 years of age | 281 |
| 30 to 39 years of age | 544 |
| 40 to 49 years of age | 589 |
| 50 to 59 years of age | 680 |
| 60 to 69 years of age | 630 |
| 70 to 79 years of age | 305 |
| 80 to 89 years of age | 92 |
| 90 years of age and older | 7 |
| Sex/Gender, Customized(Participants) | Klacid SR Treatment |
|---|---|
| Number | 3130 |
| Region of Enrollment(participants) | Klacid SR Treatment |
|---|---|
| Czech Republic | 3130 |
Showing the first 100 of 135 sites. Choose a country and city above to see the rest.
The record gives a start of Feb 2010, a primary completion of Jul 2010 and a completion of Jul 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2011, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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