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The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with respiratory tract infection | Thai patients with upper or lower respiratory tract infections on Klacid MR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clarithromycin (Klacid® MR) | Drug | Klacid MR 500mg (clarithromycin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Time From Baseline to Recovery From Cough and Other Symptoms | Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) 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, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection. | Baseline to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Type of Adverse Events | 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 is summarized. See the Reported Adverse Event section for details. | Baseline to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
Known hypersensitivity to or previously intolerant of macrolides.
Illness severe enough to warrant hospitalization or parenteral therapy.
Concomitant use of any of the following medications:
Severe immunodeficiency and chronic disease conditions.
Renal or hepatic impairment.
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Outpatients in Thailand
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| Name | Affiliation | Role |
|---|---|---|
| Savary Om, M.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27453 | Bangkok | 10160 | Thailand | |||
| Site Reference ID/Investigator# 27450 |
A total of 760 participants were enrolled in the study. 694 were analyzed as 66 participants had protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).
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| ID | Title | Description |
|---|---|---|
| FG000 | Klacid MR | Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Bangkok |
| 10210 |
| Thailand |
| Site Reference ID/Investigator# 27448 | Bangkok | 10220 | Thailand |
| Site Reference ID/Investigator# 22862 | Bangkok | 10400 | Thailand |
| Site Reference ID/Investigator# 27444 | Bangkok | 10400 | Thailand |
| Site Reference ID/Investigator# 27445 | Bangkok | 10400 | Thailand |
| Site Reference ID/Investigator# 27451 | Bangkok | 10400 | Thailand |
| Site Reference ID/Investigator# 27452 | Bangkok | 10600 | Thailand |
| Site Reference ID/Investigator# 27449 | Bangkok | 10900 | Thailand |
| Site Reference ID/Investigator# 27454 | Chiang Mai | 50180 | Thailand |
| Site Reference ID/Investigator# 27466 | Chon Buri | 20110 | Thailand |
| Site Reference ID/Investigator# 27465 | Chon Buri | 20150 | Thailand |
| Site Reference ID/Investigator# 27469 | Kanchanaburi | 71000 | Thailand |
| Site Reference ID/Investigator# 27455 | Nakhon Phanom | 48000 | Thailand |
| Site Reference ID/Investigator# 27461 | Nakhon Ratchasima | 30000 | Thailand |
| Site Reference ID/Investigator# 27462 | Nakhon Ratchasima | 30000 | Thailand |
| Site Reference ID/Investigator# 27463 | Nakhon Ratchasima | 30000 | Thailand |
| Site Reference ID/Investigator# 27457 | Nong Khai | 43000 | Thailand |
| Site Reference ID/Investigator# 27458 | Nong Khai | 43110 | Thailand |
| Site Reference ID/Investigator# 27467 | Rayong | 21000 | Thailand |
| Site Reference ID/Investigator# 27470 | Songkhla | 90110 | Thailand |
| Site Reference ID/Investigator# 27472 | Surat Thani | 84000 | Thailand |
| Site Reference ID/Investigator# 27471 | Surat Thani | 84130 | Thailand |
| Site Reference ID/Investigator# 27459 | Ubonratchathani | 34000 | Thailand |
| Site Reference ID/Investigator# 27456 | Udon Thani | 41000 | Thailand |
| Site Reference ID/Investigator# 27464 | Uttaradit | 53000 | Thailand |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Klacid MR | The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Based on per-protocol population (694 participants). | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Age, Customized | Based on per-protocol population (694 participants). | Number | participants |
| ||||||||||||||||||||||
| Sex: Female, Male | Based on per-protocol population (694 participants). | Count of Participants | Participants |
| ||||||||||||||||||||||
| Region of Enrollment | Based on per-protocol population (694 participants). | Number | participants |
| ||||||||||||||||||||||
| Diagnosis | Participant diagnosis at study entry for the per-protocol population (694 participants). | Number | participants |
| ||||||||||||||||||||||
| Risk factor: Smoking status | Whether or not participants smoked cigarettes for the per-protocol population (694 participants). | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Time From Baseline to Recovery From Cough and Other Symptoms | Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) 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, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection. | The per-protocol population consisted of 694 participants as 66 participants were excluded for protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3). | Posted | Mean | Standard Deviation | Days | Baseline to 14 days |
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| Secondary | Number and Type of Adverse Events | 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 is summarized. See the Reported Adverse Event section for details. | The safety population included all participants who took at least 1 dose of Klacid. | Posted | Number | Events | Baseline to 14 days |
|
|
All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid MR.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Klacid MR | Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information. | 0 | 760 | 5 | 760 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Muscle strain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017291 | Clarithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| 31 to 40 years |
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| 41 to 50 years |
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| 51 to 60 years |
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| Over 60 years |
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| Both upper and lower respiratory tract infections |
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