Trial · NCT01095978
Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine
NCT01095978, Completed, Abbott; results first posted 2011-06-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine. Trials, record NCT01095978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01095978
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine
- NCT number
- NCT01095978
- Status
- Completed
- Enrollment
- 2,822 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Respiratory Tract Infections
- Interventions
- Clarithromycin (Klacid SR)
- First posted
- 2010-03-30
- Last updated
- 2011-07-11
- Results first posted
- 2011-06-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Body Temperature | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups. |
| Primary | Cough and Its Character | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented. |
| Primary | Dyspnoea | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted. |
| Primary | Auscultation Findings | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2. |
| Primary | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Visit 1 (Initial visit) | Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups. |
| Primary | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Visit 1 (Initial visit) | Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups. |
| Primary | Therapeutic Response | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups. |
| Secondary | Adverse Effects | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details. |
| Secondary | Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) | Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) | Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason. |
| Secondary | Termination of Treatment | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The number of participants who discontinued treatment is summarized. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Body Temperature | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1. | Participants | NUMBER |
| PRIMARY | Cough and Its Character | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The per-protocol population was analyzed. | Participants | NUMBER |
| PRIMARY | Dyspnoea | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The per-protocol population was analyzed. | Participants | NUMBER |
| PRIMARY | Auscultation Findings | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The per-protocol population was analyzed. | Participants | NUMBER |
| PRIMARY | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Visit 1 (Initial visit) | The per-protocol population was analyzed. | Participants | NUMBER |
| PRIMARY | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Visit 1 (Initial visit) | The per-protocol population was analyzed. | Participants | NUMBER |
| PRIMARY | Therapeutic Response | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The per-protocol population was analyzed. | Participants | NUMBER |
| SECONDARY | Adverse Effects | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The per-protocol population was analyzed. | Participants | NUMBER |
| SECONDARY | Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) | Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) | The per-protocol population was analyzed. | Participants | NUMBER |
| SECONDARY | Termination of Treatment | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The per-protocol population was analyzed. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Body Temperature | Klacid SR (Total) | Visit 1: No fever | 183 | Participants | |
| Body Temperature | Klacid SR (18 to 64 Years of Age) | Visit 1: No fever | 170 | Participants | |
| Body Temperature | Klacid SR (65 Years of Age or Older) | Visit 1: No fever | 13 | Participants | |
| Body Temperature | Klacid SR (Total) | Visit 1: Fever present | 2617 | Participants | |
| Body Temperature | Klacid SR (18 to 64 Years of Age) | Visit 1: Fever present | 2434 | Participants | |
| Body Temperature | Klacid SR (65 Years of Age or Older) | Visit 1: Fever present | 183 | Participants | |
| Body Temperature | Klacid SR (Total) | a) Fever resolved at Visit 2 | 1780 | Participants | |
| Body Temperature | Klacid SR (18 to 64 Years of Age) | a) Fever resolved at Visit 2 | 1655 | Participants | |
| Body Temperature | Klacid SR (65 Years of Age or Older) | a) Fever resolved at Visit 2 | 125 | Participants | |
| Body Temperature | Klacid SR (Total) | b) Fever still present at Visit 2 | 837 | Participants |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Klacid SR | 2,822 | |
| Overall Study | COMPLETED | Klacid SR | 2,819 | |
| Overall Study | NOT COMPLETED | Klacid SR | 3 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Klacid SR | 7 | 2,800 | |
| other | Dysgeusia | Nervous system disorders | Klacid SR | 6 | 2,800 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Klacid SR | 3 | 2,800 | |
| other | Disbacteriosis | Gastrointestinal disorders | Klacid SR | 1 | 2,800 | |
| other | Alanine aminotransferase increased | Gastrointestinal disorders | Klacid SR | 1 | 2,800 | |
| other | Aspartate aminotransferase increased | Gastrointestinal disorders | Klacid SR | 1 | 2,800 | |
| other | Diarrhoea | Gastrointestinal disorders | Klacid SR | 1 | 2,800 | |
| other | Dyspepsia | Gastrointestinal disorders | Klacid SR | 1 | 2,800 | |
| other | Urticaria | Skin and subcutaneous tissue disorders | Klacid SR | 1 | 2,800 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Klacid SR | ||
| Total, other adverse events | Klacid SR | 14 | 2,800 |
| Total, serious adverse events | Klacid SR | 0 | 2,800 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01095978
GET https://conductscience.org/api/trials/v1/NCT01095978/results?page=2