Trial Outcomes & Findings for Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media (NCT NCT00189098)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

6, 12 weeks and 1 year follow-up.

Results posted on

2012-07-13

Participant Flow

Patients were recruited between February 2003 and June 2006. Otorhinolaryngologists and paediatricians from all over the Netherlands referred potential participants, i.e. children with COM that had failed conventional management with topical medications and/or short term systemic antibiotics

Participant milestones

Participant milestones
Measure	Placebo Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.	Sulfamethoxazole-trimethoprim Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
Overall Study STARTED	51	50
Overall Study COMPLETED	46	44
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=51 Participants Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.	Sulfamethoxazole-trimethoprim n=50 Participants Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.	Total n=101 Participants Total of all reporting groups
Age Continuous	51 months n=5 Participants	48 months n=7 Participants	50 months n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6, 12 weeks and 1 year follow-up.

Population: intention to treat

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.

Outcome measures

Outcome measures
Measure	Sulfamethoxazole-trimethoprim n=44 Participants The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.	Placebo n=46 Participants The children in this group received placebo orally two times a day for 6 to 12 weeks.
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear At 6 weeks	13 participants	27 participants
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear At 12 weeks	15 participants	23 participants
Number of Participants With Otomicroscopic Signs of Otorrhea in Either Ear At 12 months	11 participants	9 participants

SECONDARY outcome

Timeframe: Between 6 to12 week follow up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sulfamethoxazole-trimethoprim n=38 Participants The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.	Placebo n=39 Participants The children in this group received placebo orally two times a day for 6 to 12 weeks.
Number of Patients Who Used Additional Antibiotic Eardrops Between 6 to 12 Week Follow-up	21 participants	26 participants

SECONDARY outcome

Timeframe: between 12 weeks to 1 year follow-up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sulfamethoxazole-trimethoprim n=37 Participants The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.	Placebo n=38 Participants The children in this group received placebo orally two times a day for 6 to 12 weeks.
Number of Patients Who Used Additional Antibiotic Eardrops Between 12 Weeks to 1 Year Follow-up	29 participants	31 participants

SECONDARY outcome

Timeframe: between 6 and 12 weeks follow-up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sulfamethoxazole-trimethoprim n=38 Participants The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.	Placebo n=39 Participants The children in this group received placebo orally two times a day for 6 to 12 weeks.
Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 6 and 12 Weeks Follow-up.	4 participants	7 participants

SECONDARY outcome

Timeframe: between 12 weeks and 1 year follow-up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Sulfamethoxazole-trimethoprim n=37 Participants The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.	Placebo n=38 Participants The children in this group received placebo orally two times a day for 6 to 12 weeks.
Number of Patients Who Used Systemic Antibiotics Other Than the Study Medication Between 12 Weeks and 1 Year Follow-up.	23 participants	18 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sulfamethoxazole-trimethoprim n=44 Participants The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.	Placebo n=46 Participants The children in this group received placebo orally two times a day for 6 to 12 weeks.
Number of Patients Who Underwent Ear Nose and Throat Surgery Between 12 Weeks and 1 Year Follow-up.	13 participants	11 participants

Adverse Events

Sulfamethoxazole-trimethoprim

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sulfamethoxazole-trimethoprim n=50 participants at risk	Placebo n=51 participants at risk
Ear and labyrinth disorders Mastoiditis	2.0% 1/50 • Number of events 1 • During the first 12 weeks Using diaries	2.0% 1/51 • Number of events 1 • During the first 12 weeks Using diaries

Other adverse events

Other adverse events
Measure	Sulfamethoxazole-trimethoprim n=50 participants at risk	Placebo n=51 participants at risk
Gastrointestinal disorders vomiting or diarrhoea	8.0% 4/50 • Number of events 4 • During the first 12 weeks Using diaries	2.0% 1/51 • Number of events 1 • During the first 12 weeks Using diaries
Skin and subcutaneous tissue disorders skinrash	2.0% 1/50 • Number of events 1 • During the first 12 weeks Using diaries	0.00% 0/51 • During the first 12 weeks Using diaries

Additional Information

Prof. A. Schilder

Wilhelmina Children's Hospital, University Medical Center Utrecht

Phone: 0031 302504580

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place