Lower Respiratory Tract Infection
Conditions
Keywords
Post-marketing observational study, Lower respiratory tract infections, Klacid Granules for Oral Suspension
Brief summary
Klacid Granules for Oral Suspension provides short symptoms' recovery time in Thai children with lower respiratory tract infections.
Interventions
DRUGclarithromycin (Klacid) granules for oral suspension
clarithromycin (Klacid) Granules for Oral Suspension
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients with lower respiratory tract infection. * Patient is male or female \> 6 months and \< 12 years of age. * Prescription of Klacid Granules for Oral Suspension is at the discretion of the investigators according to the clinical condition of the patients * Patients who are suitable for treatment with Klacid Granules for Oral Suspension according to the Prescribing Information
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 * 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 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
| 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 are summarized. See the Reported Adverse Event section for details. |
Countries
Thailand
Participant flow
Pre-assignment details
A total of 337 participants were enrolled in the study. 308 were analyzed as 29 participants had 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).
Participants by arm
| Arm | Count |
|---|---|
| Klacid Granules (Total) The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information. | 308 |
| Total | 308 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Symptoms improved/resolved | 6 |
Baseline characteristics
| Characteristic | Klacid Granules (Total) |
|---|---|
| Age Continuous | 4.2 years |
| Age, Customized > 5 and < 12 years | 110 participants |
| Age, Customized > 6 months to 3 years | 80 participants |
| Age, Customized Between 3 and 5 years | 118 participants |
| Diagnosis Bronchitis | 278 participants |
| Diagnosis Pneumonia | 30 participants |
| Region of Enrollment Thailand | 308 participants |
| Risk Factor--Lower Respiratory Tract Infections LRTI > 10 times per year | 0 participants |
| Risk Factor--Lower Respiratory Tract Infections LRTI 1 to 2 times per year | 111 participants |
| Risk Factor--Lower Respiratory Tract Infections LRTI 3 to 6 times per year | 27 participants |
| Risk Factor--Lower Respiratory Tract Infections LRTI 7 to 10 times per year | 9 participants |
| Risk Factor--Lower Respiratory Tract Infections LRTI not reported | 161 participants |
| Risk Factor--Upper Respiratory Tract Infections URTI > 10 times per year | 0 participants |
| Risk Factor--Upper Respiratory Tract Infections URTI 1 to 2 times per year | 98 participants |
| Risk Factor--Upper Respiratory Tract Infections URTI 3 to 6 times per year | 76 participants |
| Risk Factor--Upper Respiratory Tract Infections URTI 7 to 10 times per year | 5 participants |
| Risk Factor--Upper Respiratory Tract Infections URTI not reported | 129 participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 337 |
| serious Total, serious adverse events | 2 / 337 |
Outcome results
Primary
Average Time From Baseline to Recovery From Fever and Other Symptoms
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.
Time frame: Baseline to 14 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Klacid Granules (Total Number Recovered) | Average Time From Baseline to Recovery From Fever and Other Symptoms | 7.18 Days | Standard Deviation 2.33 |
| Klacid Granules (Bronchitis, Recovered) | Average Time From Baseline to Recovery From Fever and Other Symptoms | 7.14 Days | Standard Deviation 2.35 |
| Klacid Granules (Pneumonia, Recovered) | Average Time From Baseline to Recovery From Fever and Other Symptoms | 7.88 Days | Standard Deviation 1.81 |
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 are 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 Granules (Total Number Recovered) | Number and Type of Adverse Events | Non-serious adverse events | 1 Participants |
| Klacid Granules (Total Number Recovered) | Number and Type of Adverse Events | Serious adverse events | 2 Participants |