Trial · NCT02554383
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
NCT02554383, Phase 3, Completed, Nader Shaikh; results first posted 2023-06-08
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit? Trials, record NCT02554383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02554383
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit?
- NCT number
- NCT02554383
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 515 participants, actual
- Lead sponsor
- Nader Shaikh
- Conditions
- Sinusitis, Respiratory Tract Infections
- Interventions
- Amoxicillin-clavulanate, Placebo
- First posted
- 2015-09-18
- Last updated
- 2023-06-29
- Results first posted
- 2023-06-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Days 2 to 11 | The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Pathogens cultured were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. |
| Primary | The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment | Days 2 to 11 | The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) \& electronically on diaries evenings Days 2-11. Nasal discharge, either yellow or green, was considered colored. |
| Secondary | The Distribution of Children Experiencing Treatment Failure (TF) | Day of enrollment to the day of the follow-up visit. The mean length of actual follow-up was 13.4 days. For each child with incomplete follow-up, multiple imputation was used and PRSS scores for the remaining days were imputed. | The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough \& trouble sleeping - as none, almost none, a little, some, a lot \& an extreme amount with respective scores of 0, 1, 2, 3, 4 \& 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment), electronically evenings Days 2-11 \& at the follow-up visit. If, compared to the Day 1 score, there was \>20% increase at any time, decrease \<2 on Day 3, \<20% decrease on Day 4, \<20% decrease on 2 consecutive occasions Days 5-11 or \<50% decrease at follow-up, then criterion for treatment failure (TF) was met. Multiple imputation was used when data was insufficient to assess TF. |
| Secondary | The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up | Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8. | AOM is an infection of the middle ear marked by acute symptoms and a bulging tympanic membrane. Its diagnosis coincided with receipt of a systemic antibiotic. Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin \& Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded. |
| Secondary | The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up | Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8. | Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin \& Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded. The antibiotic received is exclusive of the study product assigned at enrollment. |
| Secondary | The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported | Day 1 through Day 23. | The monitoring of adverse events (AEs), i.e. diarrhea or generalized rash, began on Day 1 (enrollment) and continued through Day 23 (the follow-up visit). Diarrhea was the occurrence of 3 or more watery stools on one day or 2 watery stools on each of 2 consecutive days. Parents recorded in daily diaries, Days 1-11, information regarding the occurrence of diarrhea. Additionally, parents were asked at the follow-up visit if their child had diarrhea while on study product. |
| Secondary | The Distribution of Children Compliant With Study Medication | Days 1 to 11, where Day 1 is day of enrollment | Compliance, expressed as a percentage, is the total number of doses taken divided by the total number of expected doses. The child is considered compliant if he/she has received at least 70% of the study medication. The parent completed diaries evenings Days 2-11. The diaries included yes/no questions - (1) did your child take the study medication last night and (2) did your child take the study medication this morning? The total number of doses taken was calculated based on the responses to question (1), and accounted for the dose dispensed at enrollment when enrollment was 1pm or earlier on Day 1. The total of expected doses was determined from the responses to questions (1) and (2), and accounted for scenarios in which the child was taken off the study medication by the clinician. In some cases, due to incomplete diaries the information was insufficient to declare a child either compliant or not compliant. |
| Other | The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit | The follow-up visit. The mean number of days from enrollment to the follow-up visit was 13.4. | The nonsusceptible pathogens considered are penicillin-intermediate and penicillin-resistant Streptococcus pneumoniae (SPN) and ß-lactamase-positive Haemophilus influenzae (NTHi). Susceptibility to penicillin was defined as follows: susceptible as a minimum inhibitory concentration (MIC) of \<=0.06 μg/mL; intermediate as an MIC of greater than 0.06 to less than 2 μg/mL; and resistant as an MIC of \>=2 μg/mL. A nasopharyngeal specimen for bacterial culture was obtained at the time of the follow-up visit, occurring between study days 11 and 23. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Days 2 to 11 | The analysis was intention-to-treat (ITT). The overall number of participants analyzed is equal to the number of children randomized \& eligible who had results of a nasopharyngeal culture at enrollment and whose parent completed the PRSS at least once Days 2 to 11. For any given day, the total number analyzed plus the total number without diary data available on that day is equal to the overall number of participants analyzed for the respective Arm/Group. | Score on a scale | MEAN |
| PRIMARY | The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment | Days 2 to 11 | The analysis was ITT. The overall number of participants analyzed is equal to the number of children randomized \& eligible whose parent completed the PRSS at least once Days 2 to 11. For any given day, the total number analyzed plus the total number without diary data available on that day is equal to the overall number of participants analyzed for the respective Arm/Group. | Score on a scale | MEAN |
| SECONDARY | The Distribution of Children Experiencing Treatment Failure (TF) | Day of enrollment to the day of the follow-up visit. The mean length of actual follow-up was 13.4 days. For each child with incomplete follow-up, multiple imputation was used and PRSS scores for the remaining days were imputed. | The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up | Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8. | The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with follow-up post-enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up | Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8. | The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with follow-up post-enrollment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported | Day 1 through Day 23. | The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Distribution of Children Compliant With Study Medication | Days 1 to 11, where Day 1 is day of enrollment | The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with information sufficient to determine compliance. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit | The follow-up visit. The mean number of days from enrollment to the follow-up visit was 13.4. | The analysis was ITT. The number of participants is equal to the number of children randomized \& eligible with a nasopharyngeal specimen obtained at the time of the follow-up visit | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Amoxicillin-clavulanate | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 2 | 17.3 | Standard Deviation 7.8 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Placebo | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 2 | 18.6 | Standard Deviation 7.6 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Amoxicillin-clavulanate | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 3 | 13.9 | Standard Deviation 7.7 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Placebo | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 3 | 16.6 | Standard Deviation 7.5 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Amoxicillin-clavulanate | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 4 | 11.8 | Standard Deviation 7.9 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Placebo | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 4 | 13.9 | Standard Deviation 7.6 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Amoxicillin-clavulanate | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 5 | 10.1 | Standard Deviation 7.6 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Placebo | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 5 | 12.0 | Standard Deviation 7.0 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Amoxicillin-clavulanate | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 6 | 8.5 | Standard Deviation 7.1 | Score on a scale |
| The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment | Placebo | Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 6 | 10.9 | Standard Deviation 6.9 | Score on a scale |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amoxicillin-clavulanate | 257 | |
| Overall Study | STARTED | Placebo | 258 | |
| Overall Study | COMPLETED | Amoxicillin-clavulanate | 234 | |
| Overall Study | COMPLETED | Placebo | 239 | |
| Overall Study | NOT COMPLETED | Amoxicillin-clavulanate | 23 | |
| Overall Study | NOT COMPLETED | Placebo | 19 |
Source ClinicalTrials.gov
Adverse events2
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 | Diarrhea | Gastrointestinal disorders | Amoxicillin-clavulanate | 29 | 254 | 31 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 12 | 256 | 13 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amoxicillin-clavulanate | 0 | 254 |
| Total, all-cause mortality | Placebo | 0 | 256 |
| Total, other adverse events | Amoxicillin-clavulanate | 29 | 254 |
| Total, other adverse events | Placebo | 12 | 256 |
| Total, serious adverse events | Amoxicillin-clavulanate | 0 | 254 |
| Total, serious adverse events | Placebo | 0 | 256 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37490085 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI118506 | Efficacy of Antibiotics in Children with Acute Sinusitis: Which Subgroups Benefit? | SHAIKH, NADER; WALD, ELLEN | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2015 to 2019 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Amoxicillin-clavulanate vs Placebo: deaths from any cause | Trial comparisons |
| Amoxicillin-clavulanate vs Placebo: serious adverse events | Trial comparisons |
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/NCT02554383
GET https://conductscience.org/api/trials/v1/NCT02554383/results?page=2