Respiratory Tract Infection
Conditions
Keywords
Post-marketing observational study, Upper or lower respiratory tract infection, Klacid MR
Brief summary
The investigators hypothesize that Klacid modified release (MR) shortens symptom recovery time in Thai patients with upper or lower respiratory tract infections.
Interventions
DRUGClarithromycin (Klacid® MR)
Klacid MR 500mg (clarithromycin)
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with upper or lower respiratory tract infection. * Patient is male or female ≥ 18 years of age.
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: * Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine. * Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate. * Colchicine * Digoxin * Some antiretrovirals: zidovudine and ritonavir. * Severe immunodeficiency and chronic disease conditions. * Renal or hepatic impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Time From Baseline to Recovery From Cough and Other Symptoms | Baseline to 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 is summarized. See the Reported Adverse Event section for details. |
Countries
Thailand
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 694 |
| Total | 694 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Symptoms improved/resolved | 10 |
Baseline characteristics
| Characteristic | Klacid MR |
|---|---|
| Age Continuous | 41.16 years STANDARD_DEVIATION 14.22 |
| Age, Customized 18 to 20 years | 28 participants |
| Age, Customized 21 to 30 years | 154 participants |
| Age, Customized 31 to 40 years | 204 participants |
| Age, Customized 41 to 50 years | 141 participants |
| Age, Customized 51 to 60 years | 102 participants |
| Age, Customized Over 60 years | 65 participants |
| Diagnosis Both upper and lower respiratory tract infections | 19 participants |
| Diagnosis Lower respiratory tract infection | 165 participants |
| Diagnosis Upper respiratory tract infection | 510 participants |
| Region of Enrollment Thailand | 694 participants |
| Risk factor: Smoking status Participant did not smoke | 530 participants |
| Risk factor: Smoking status Participant was a smoker | 164 participants |
| Sex: Female, Male Female | 404 Participants |
| Sex: Female, Male Male | 290 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 760 |
| serious Total, serious adverse events | 0 / 760 |
Outcome results
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.
Time frame: Baseline to 14 days
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Klacid MR (Total Number Recovered) | Average Time From Baseline to Recovery From Cough and Other Symptoms | 7.06 Days | Standard Deviation 2.65 |
| Klacid MR (URTI, Recovered) | Average Time From Baseline to Recovery From Cough and Other Symptoms | 6.76 Days | Standard Deviation 2.11 |
| Klacid MR (LRTI, Recovered) | Average Time From Baseline to Recovery From Cough and Other Symptoms | 7.82 Days | Standard Deviation 3.75 |
| Klacid MR (URTI and LRTI, Recovered) | Average Time From Baseline to Recovery From Cough and Other Symptoms | 9.05 Days | Standard Deviation 3.08 |
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.
Time frame: Baseline to 14 days
Population: The safety population included all participants who took at least 1 dose of Klacid.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid MR (Total Number Recovered) | Number and Type of Adverse Events | Serious Adverse Events | 0 Events |
| Klacid MR (Total Number Recovered) | Number and Type of Adverse Events | Non-serious Adverse Events | 7 Events |