A Phase 4 interventional study of Augmentin (ES)-600 in Otitis Media, Infections, Respiratory Tract and Respiratory Tract Infections, sponsored by GlaxoSmithKline. Completed at 13 sites in India. Open to participants aged 6 Months to 12 Years. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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Among 11 studies in Otitis Media by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Otitis Media · GlaxoSmithKline.
Among the 11 studies in Otitis Media by GlaxoSmithKline, this one is the only one that started in 2022, is the only one in phase 4, and was the 11th registered.
241 studies on the registry are indexed under Otitis Media; 32 are open to participants now.
Browse Otitis Media studies →None of the 11 studies in Otitis Media by GlaxoSmithKline is open now. The open studies under Otitis Media, anywhere →
Of the 20 Otitis Media studies recruiting now, 5 (25%) set no upper age limit and 15 (75%) stop at 75 or younger; 19 take children under 18; 4 take healthy volunteers.
This study: 6 Months to 12 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2022.
This study's enrollment of 310 is above the median of 165 across 174 interventional studies indexed under Otitis Media.
Median enrollment 6,181 across the 5 interventional studies, 38 across the 6 observational. Of the 11 that completed or were terminated, 5 (45%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Otitis Media by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses. Most physicians in India use the standard Augmentin (amoxicillin:clavulanic acid 7:1) (45/6.4 mg/kg/day) formulation and double the dose to achieve higher dose of amoxicillin/clavulanic acid at 90 mg/kg/day in pediatric acute otitis media (AOM) due to non-availability of Augmentin (ES)-600. Using the 7:1 formulation causes unnecessary exposure to higher proportionate dose of clavulanic acid (12.8 mg/kg/day) as a unit dose of 6.4 mg/kg/day of clavulanic acid is only required for efficacy against beta-lactamase producing AOM pathogens. Hence, there is an unmet need for availability of Augmentin (ES)-600 in India. This is an open label, single arm, multicenter, non-comparative study in participants aged 6 months to 12 years with AOM. It aims to assess the safety and clinical efficacy of Augmentin (ES)-600 administered in two divided doses, every 12 hours in pediatric population in India. AUGMENTIN is a registered trademark of the GlaxoSmithKline group of companies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of AOM on basis of otoscopic findings as defined below:
Middle ear effusion is evidenced by at least two of the following:
At least one of the following indicators of acute inflammation:
Distinct fullness or bulging of the tympanic membrane.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants will receive Augmentin (ES)-600 at 90/6.4 mg/kg/day administered in two divided doses, every 12 hours with food for 10 days.
Drug: Augmentin (ES)-600
Augmentin ES will be administered as reconstituted oral suspension containing Amoxicillin and Potassium Clavulanate 600 mg/42.9 mg per 5 milliliters.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A treatment emergent AE event has its onset date on or after treatment start date and on or before treatment stop date + 1 day
Time frame: Up to 28 days
Number of Participants With Early Clinical Response at On-therapy (OT) Visit
Early clinical response was categorized as treatment 'success' or treatment 'failure' at OT Visit (Day 3 to 5). Success was defined as 'clinical cure' that included sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy was indicated or 'improvement' that included improvement in at least 1 presenting signs/symptoms such that no additional antibiotic indicated. Failure is defined as 'Clinical Failure' that included as non-improvement or deterioration in any sign/symptoms after 2 or more days of therapy and additional antibiotic therapy is indicated or 'Unable to Determine' included a valid assessment of clinical outcome could not be made (eg, participant did not attend or consent to clinical examination or lost to follow-up). Participants who were not taking minimum 4 doses in two days were categorized as non evaluable.
Time frame: On-therapy (OT) visit (Day 3 to 5)
Number of Participants With Primary Clinical Response at End of Therapy (EOT)
Primary clinical response at the end-of-therapy visit was categorized as treatment 'success' or treatment 'failure'. Success was defined as 'Clinical Cure' that included sufficient resolution or improvement of the signs and symptoms that no additional antibiotic therapy was indicated or 'Improvement' that included improvement, but incomplete resolution of presenting signs/symptoms and no additional antibiotic indicated. Failure is defined as 'Clinical Failure' that included non-improvement or deterioration in any sign/symptoms after 2 or more days of therapy and additional antibiotic therapy indicated, or 'Unable to determine' defined as a valid assessment of clinical outcome could not be made (e.g., participant did not attend or consent to clinical examination or lost to follow-up). Non-Evaluable is defined as participants who had less than (\<) 80% compliance
Time frame: End of therapy visit (Day 12 to 14)
Number of Participants With Secondary Clinical Response at Follow-up (FU)
Secondary clinical response at follow-up was categorized as treatment 'success' or treatment 'failure'. Success was defined as 'Persistent clinical cure' that included sufficient resolution of signs/symptoms for those participants who were clinically cured or improved at the end of therapy and no additional antibiotic indicated. Failure was defined as 'Clinical recurrence' that included reappearance of signs/symptoms for those participants who were clinically cured or improved at the end of therapy and additional antibiotic therapy was indicated, or 'Unable to determine' that included valid assessment of clinical outcome could not be made (e.g., participant did not attend end of therapy visit, or extenuating circumstances or lost to follow-up). Participant with missing responses were categorized as 'Missing'.
Time frame: Follow up visit (Day 22 to 28)
Number of Participants With Protocol-defined Diarrhea (PDD) (Due to Study Medication)
Protocol-defined diarrhea was defined as a) 3 or more watery stools in one day or b) 4 or more loose/watery stools in one day or c) 2 watery stools per day for two consecutive days or d) 3 loose/watery stools per day for two consecutive days.
Time frame: From OT visit (Day 3 to 5) to FU visit (Day 22-28)
This study was an open label, multicenter, non-comparative study. Participants were children aged between 6 months to 12 years, presenting with Acute respiratory tract infections (ARTIs) including Acute otitis media (AOM), Acute bacterial rhinosinusitis (ABRS) and Community acquired bacterial pneumonia (CABP)
| Milestone | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 |
|---|---|---|---|
| Started | 136 | 106 | 68 |
| Completed | 133 | 104 | 67 |
| Not completed | 3 | 2 | 1 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 0 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A treatment emergent AE event has its onset date on or after treatment start date and on or before treatment stop date + 1 day
| Participants | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 |
|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 10 | 3 | 3 |
Early clinical response was categorized as treatment 'success' or treatment 'failure' at OT Visit (Day 3 to 5). Success was defined as 'clinical cure' that included sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy was indicated or 'improvement' that included improvement in at least 1 presenting signs/symptoms such that no additional antibiotic indicated. Failure is defined as 'Clinical Failure' that included as non-improvement or deterioration in any sign/symptoms after 2 or more days of therapy and additional antibiotic therapy is indicated or 'Unable to Determine' included a valid assessment of clinical outcome could not be made (eg, participant did not attend or consent to clinical examination or lost to follow-up). Participants who were not taking minimum 4 doses in two days were categorized as non evaluable.
| Participants | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 |
|---|---|---|---|
| Success | 134 | 104 | 68 |
| Failure | 1 | 0 | 0 |
| Non Evaluable | 1 | 2 | 0 |
Primary clinical response at the end-of-therapy visit was categorized as treatment 'success' or treatment 'failure'. Success was defined as 'Clinical Cure' that included sufficient resolution or improvement of the signs and symptoms that no additional antibiotic therapy was indicated or 'Improvement' that included improvement, but incomplete resolution of presenting signs/symptoms and no additional antibiotic indicated. Failure is defined as 'Clinical Failure' that included non-improvement or deterioration in any sign/symptoms after 2 or more days of therapy and additional antibiotic therapy indicated, or 'Unable to determine' defined as a valid assessment of clinical outcome could not be made (e.g., participant did not attend or consent to clinical examination or lost to follow-up). Non-Evaluable is defined as participants who had less than (\<) 80% compliance
| Participants | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 |
|---|---|---|---|
| Success | 132 | 104 | 67 |
| Failure | 2 | 0 | 1 |
| Non Evaluable | 2 | 2 | 0 |
Secondary clinical response at follow-up was categorized as treatment 'success' or treatment 'failure'. Success was defined as 'Persistent clinical cure' that included sufficient resolution of signs/symptoms for those participants who were clinically cured or improved at the end of therapy and no additional antibiotic indicated. Failure was defined as 'Clinical recurrence' that included reappearance of signs/symptoms for those participants who were clinically cured or improved at the end of therapy and additional antibiotic therapy was indicated, or 'Unable to determine' that included valid assessment of clinical outcome could not be made (e.g., participant did not attend end of therapy visit, or extenuating circumstances or lost to follow-up). Participant with missing responses were categorized as 'Missing'.
| Participants | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 |
|---|---|---|---|
| Success | 130 | 104 | 66 |
| Failure | 0 | 0 | 1 |
| Missing | 6 | 2 | 1 |
Protocol-defined diarrhea was defined as a) 3 or more watery stools in one day or b) 4 or more loose/watery stools in one day or c) 2 watery stools per day for two consecutive days or d) 3 loose/watery stools per day for two consecutive days.
| Participants | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 |
|---|---|---|---|
| Number of Participants With Protocol-defined Diarrhea (PDD) (Due to Study Medication) | 0 | 1 | 0 |
Collected over All Cause Mortality, Serious Adverse events and Non Serious Adverse events were collected from visit 1 (Day 1) up to follow-up visit (Day 22 to 28). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | 0/136 (0%) | 0/136 (0%) | 10/136 (7.4%) |
| Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | 0/106 (0%) | 0/106 (0%) | 3/106 (2.8%) |
| Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 | 0/68 (0%) | 0/68 (0%) | 3/68 (4.4%) |
| Event | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 5/136 | 1/106 | 0/68 |
| VomitingGastrointestinal disorders | 3/136 | 1/106 | 2/68 |
| Decreased appetiteMetabolism and nutrition disorders | 2/136 | 0/106 | 1/68 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/136 | 1/106 | 0/68 |
| Age, Continuous(Years) | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 | Total |
|---|---|---|---|---|
| Mean | 3.869 ± 2.9995 | 4.404 ± 3.0134 | 2.592 ± 2.0324 | 3.772 ± 2.8913 |
| Sex: Female, Male(Participants) | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 | Total |
|---|---|---|---|---|
| Female | 60 | 39 | 16 | 115 |
| Male | 76 | 67 | 52 | 195 |
| Ethnicity (NIH/OMB)(Participants) | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 136 | 106 | 68 | 310 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Participants With Acute Otitis Media (AOM) Receiving Augmentin (ES)-600 | Participants With Acute Bacterial Rhinosinusitis (ABRS) Receiving Augmentin (ES)-600 | Participants With Community Acquired Bacterial Pneumonia (CABP) Receiving Augmentin (ES)-600 | Total |
|---|---|---|---|---|
| Asian | 136 | 106 | 68 | 310 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from May 2022 to primary completion in Nov 2022, 6 months.
Results were first posted in Apr 2024, 1 year 5 months after primary completion.
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