Trial · NCT00189098

Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media

NCT00189098, Not applicable, Completed, UMC Utrecht; results first posted 2012-07-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media. Trials, record NCT00189098. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00189098

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media
NCT number: NCT00189098
Status: Completed
Phases: Not applicable
Enrollment: 101 participants, actual
Lead sponsor: UMC Utrecht
Conditions: Chronic Otitis Media
Interventions: Sulfamethoxazole-trimethoprim, Placebo
First posted: 2005-09-16
Last updated: 2012-07-13
Results first posted: 2012-07-13

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	6, 12 weeks and 1 year follow-up.	The primary endpoint was otomicroscopic signs of otorrhea in either ear in the presence of a tympanostomy tube or tympanic membrane perforation at 6 and 12 weeks and 1 year follow-up. At these follow-up moments the participants were checked for the presence of otorrhea using an otomicroscope.
Secondary	Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up	Between 6 to12 week follow up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.
Secondary	Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up	between 12 weeks to 1 year follow-up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits.
Secondary	Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.	between 6 and 12 weeks follow-up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.
Secondary	Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.	between 12 weeks and 1 year follow-up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits.
Secondary	Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.	between 12 weeks and 1 year follow-up	After 12 weeks follow-up irrespective of the presence or absence of otorrhea the study medication was discontinued. After the first 12 weeks local otorhinolaryngologists and paediatricians were free to manage symptoms of otorrhea according to their regular practice. Parents kept a diary between 12 weeks and 1 year follow-up where Ear Nose and Throat Surgery was noted. This outcome describes the number of patients who underwent Ear Nose and Throat Surgery between 12 weeks and 1 year follow-up.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	6, 12 weeks and 1 year follow-up.	intention to treat	participants	NUMBER
SECONDARY	Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up	Between 6 to12 week follow up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.	participants	NUMBER
SECONDARY	Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up	between 12 weeks to 1 year follow-up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including eardrops. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis. Therefore number of participants analyzed differ from the flow-chart.	participants	NUMBER
SECONDARY	Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.	between 6 and 12 weeks follow-up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.	participants	NUMBER
SECONDARY	Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.	between 12 weeks and 1 year follow-up	Parents kept a diary of study medication and additional medication used for their child's' ear disease, including additional use of systemic antibiotics other than the study medication. These data were collected at the follow-up visits. Some parents did not fill in the required forms and these were excluded in this analysis.	participants	NUMBER
SECONDARY	Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.	between 12 weeks and 1 year follow-up		participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	Sulfamethoxazole-trimethoprim	At 6 weeks	13	participants
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	Placebo	At 6 weeks	27	participants
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	Sulfamethoxazole-trimethoprim	At 12 weeks	15	participants
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	Placebo	At 12 weeks	23	participants
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	Sulfamethoxazole-trimethoprim	At 12 months	11	participants
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear	Placebo	At 12 months	9	participants
Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up	Sulfamethoxazole-trimethoprim		21	participants
Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up	Placebo		26	participants
Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up	Sulfamethoxazole-trimethoprim		29	participants
Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up	Placebo		31	participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	51
Overall Study	STARTED	Sulfamethoxazole-trimethoprim	50
Overall Study	COMPLETED	Placebo	46
Overall Study	COMPLETED	Sulfamethoxazole-trimethoprim	44
Overall Study	NOT COMPLETED	Placebo	5
Overall Study	NOT COMPLETED	Sulfamethoxazole-trimethoprim	6

Source ClinicalTrials.gov

Adverse events6

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	vomiting or diarrhoea	Gastrointestinal disorders	Sulfamethoxazole-trimethoprim	4	50	4
other	vomiting or diarrhoea	Gastrointestinal disorders	Placebo	1	51	1
other	skinrash	Skin and subcutaneous tissue disorders	Sulfamethoxazole-trimethoprim	1	50	1
other	skinrash	Skin and subcutaneous tissue disorders	Placebo	0	51	0
serious	Mastoiditis	Ear and labyrinth disorders	Sulfamethoxazole-trimethoprim	1	50	1
serious	Mastoiditis	Ear and labyrinth disorders	Placebo	1	51	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sulfamethoxazole-trimethoprim
Total, all-cause mortality	Placebo
Total, other adverse events	Sulfamethoxazole-trimethoprim	4	50
Total, other adverse events	Placebo	1	51
Total, serious adverse events	Sulfamethoxazole-trimethoprim	1	50
Total, serious adverse events	Placebo	1	51

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17473089	RESULT	PubMed
19297377	DERIVED	PubMed

Grants0

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.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sulfamethoxazole-trimethoprim vs Placebo: Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up	Trial comparisons
Sulfamethoxazole-trimethoprim vs Placebo: Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.	Trial comparisons
Sulfamethoxazole-trimethoprim vs Placebo: Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.	Trial comparisons
Sulfamethoxazole-trimethoprim vs Placebo: Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up	Trial comparisons
Sulfamethoxazole-trimethoprim vs Placebo: Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.	Trial comparisons
Sulfamethoxazole-trimethoprim 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00189098

GET https://conductscience.org/api/trials/v1/NCT00189098/registered

API reference For AI assistants