Trial · NCT01076166
Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
NCT01076166, Completed, Abbott; results first posted 2011-03-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension. Trials, record NCT01076166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01076166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.
- NCT number
- NCT01076166
- Status
- Completed
- Enrollment
- 337 participants, actual
- Lead sponsor
- Abbott
- Conditions
- Lower Respiratory Tract Infection
- Interventions
- clarithromycin (Klacid) granules for oral suspension
- First posted
- 2010-02-26
- Last updated
- 2011-04-11
- Results first posted
- 2011-03-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Time From Baseline to Recovery From Fever and Other Symptoms | Baseline to 14 days | Participants were observed during his/her Klacid treatment (5 to 14 days). A medical appointment was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, fever, cough, chest/abdominal pain, and vomiting. Recovery was defined as the disappearance of all signs and symptoms of infection. |
| Secondary | Number and Type of Adverse Events | Baseline to 14 days | Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event are summarized. See the Reported Adverse Event section for details. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Time From Baseline to Recovery From Fever and Other Symptoms | Baseline to 14 days | A total of 29 patients were excluded for protocol deviations: Took Klacid less than 5 days (9), took Klacid more than 14 days (4), Klacid intravenous formulation used instead of granules (9), participants enrolled prior to signed study agreement (5), and age less than 6 months (2). Average time to recovery was based on 171 recovered patients. | Days | MEAN |
| SECONDARY | Number and Type of Adverse Events | Baseline to 14 days | The safety population included all participants who took at least 1 dose of Klacid. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Time From Baseline to Recovery From Fever and Other Symptoms | Klacid Granules (Total Number Recovered) | 7.18 | Standard Deviation 2.33 | Days | |
| Average Time From Baseline to Recovery From Fever and Other Symptoms | Klacid Granules (Bronchitis, Recovered) | 7.14 | Standard Deviation 2.35 | Days | |
| Average Time From Baseline to Recovery From Fever and Other Symptoms | Klacid Granules (Pneumonia, Recovered) | 7.88 | Standard Deviation 1.81 | Days | |
| Number and Type of Adverse Events | Klacid Granules (Total) | Serious adverse events | 2 | Participants | |
| Number and Type of Adverse Events | Klacid Granules (Total) | Non-serious adverse events | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Klacid Granules (Total) | 337 | |
| Overall Study | COMPLETED | Klacid Granules (Total) | 328 | |
| Overall Study | NOT COMPLETED | Klacid Granules (Total) | 9 |
Source ClinicalTrials.gov
Adverse events7
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 | Vomiting | Gastrointestinal disorders | Klacid Granules (Total) | 1 | 337 | 1 |
| serious | Drug ineffective | General disorders | Klacid Granules (Total) | 1 | 337 | 1 |
| serious | Pneumonia | Infections and infestations | Klacid Granules (Total) | 1 | 337 | 1 |
| serious | Pneumonia viral | Infections and infestations | Klacid Granules (Total) | 1 | 337 | 1 |
| serious | Asthma | Respiratory, thoracic and mediastinal disorders | Klacid Granules (Total) | 1 | 337 | 1 |
| serious | Cough | Respiratory, thoracic and mediastinal disorders | Klacid Granules (Total) | 1 | 337 | 1 |
| serious | Hypophagia | Metabolism and nutrition disorders | Klacid Granules (Total) | 1 | 337 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Klacid Granules (Total) | ||
| Total, other adverse events | Klacid Granules (Total) | 1 | 337 |
| Total, serious adverse events | Klacid Granules (Total) | 2 | 337 |
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/NCT01076166
GET https://conductscience.org/api/trials/v1/NCT01076166/registered