Chronic Subdural HematomasPhase 2/3iSDHNCT07556991
Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
A Phase 2/3 study testing Amoxicillin + clavulanic acid in people with Chronic Subdural Hematomas, run by University of Rostock at 1 site in Germany.
Trial summary
Chronic subdural hematoma (cSDH) is a very common disease, primarily affecting older people, and is associated with significant morbidity and mortality. The incidence described in the literature is approximately 5 per 100,000/year, but it occurs more frequently in the elderly, with up to 58 per 100,000/year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematomas
- What is being tested?
- Amoxicillin + clavulanic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2024to 30 Jun 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- surgical treatment of chronic subdural hematoma
Who cannot join
- prior or current antibiotic treatment
- infection
- recurrent chronic subdural hematoma
- conservatively treated chronic subdural hematoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
UnIversity Medical Center Rostock
Rostock, 18057
Daniel PD. Dr. med. habil. Dubinski, MD MSc, +49 381 494 6439, daniel.dubinski@med.uni-rostock.de
Sae-Yeon Won, MD, +49 381 494 6439, sae-yeon.won@med.uni-rostock.de
About this study
Chronic subdural hematoma (cSDH) is a very common disease, primarily affecting older people, and is associated with significant morbidity and mortality. The incidence described in the literature is approximately 5 per 100,000/year, but it occurs more frequently in the elderly, with up to 58 per 100,000/year. The recurrence rate is high and is described in the literature as 10 to 27%. Consequently, various studies have evaluated potential risk factors for hematoma recurrence, such as age, brain atrophy, mixed HU density in CCT, increased body mass index, and bilateral hematomas. The pathomechanism of recurrence is currently unknown.
The mechanism of development after minor trauma and the progression of the hematoma to a symptomatic form remain unclear. A recent retrospective investigation submitted for publication by the applicant, regarding the occurrence of a low-grade infection in patients with recurrent hematomas, examined this as a possible cause. In this study, microbiological swabs were taken from the subdural space after hematoma evacuation. It was shown that a low-grade infection could be detected in approximately 30% of all hematoma recurrences. This is previously unknown in the neurosurgical literature. This raises the question of whether a low-grade infection is already present in the primary chronic subdural hematoma.
- Conditions
- Chronic Subdural Hematomas
- Being tested
- Amoxicillin + clavulanic acid, Placebo ( FE)
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin + clavulanic acidDrug
Participants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively.
Placebo ( FE)Drug
Participants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic Arm | Experimental | Treatment with oral antibiotics for 10 days after surgical treatment Receives: Drug: Amoxicillin + clavulanic acid |
| Placebo group | Placebo comparator | Placebo oral drug administration 10 days after surgical treatment Receives: Drug: Placebo ( FE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-operation within six months
The primary objective is to determine if this postoperative antibiotic course reduces the rate of symptomatic cSDH recurrence requiring re-operation within six months. A pre-planned subgroup analysis will be conducted to compare outcomes specifically for patients with a positive microbiological culture versus those with a negative culture.
Measured: 6 months
Secondary outcomes (1)
type of bacterial colonisation
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sae-Yeon Won, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556991
- Sponsor's protocol ID
- UMR2
- Acronym
- iSDH
- Status last verified
- Oct 2025
- First submitted
- 22 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Investigation on Infection as a Cause of Chronic Subdural Hematoma.
- ClinicalTrials.gov ID
- NCT07556991
- Acronym / sponsor ID
- iSDH / UMR2
- Conditions
- Chronic Subdural Hematomas
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic subdural hematoma (cSDH) is a very common disease, primarily affecting older people, and is associated with significant morbidity and mortality. The incidence described in the literature is approximately 5 per 100,000/year, but it occurs more frequently in the elderly, with up to 58 per 100,000/year. The recurrence rate is high and is described in the literature as 10 to 27%. Consequently, various studies have evaluated potential risk factors for hematoma recurrence, such as age, brain atrophy, mixed HU density in CCT, increased body mass index, and bilateral hematomas. The pathomechanism of recurrence is currently unknown.
The mechanism of development after minor trauma and the progression of the hematoma to a symptomatic form remain unclear. A recent retrospective investigation submitted for publication by the applicant, regarding the occurrence of a low-grade infection in patients with recurrent hematomas, examined this as a possible cause. In this study, microbiological swabs were taken from the subdural space after hematoma evacuation. It was shown that a low-grade infection could be detected in approximately 30% of all hematoma recurrences. This is previously unknown in the neurosurgical literature. This raises the question of whether a low-grade infection is already present in the primary chronic subdural hematoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic Arm | Experimental | Drug: Amoxicillin + clavulanic acidTreatment with oral antibiotics for 10 days after surgical treatment |
| Placebo group | Placebo comparator | Drug: Placebo ( FE)Placebo oral drug administration 10 days after surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years of age
- surgical treatment of chronic subdural hematoma
Key exclusion criteria (4 listed)
- prior or current antibiotic treatment
- infection
- recurrent chronic subdural hematoma
- conservatively treated chronic subdural hematoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin + clavulanic acidParticipants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively. | Drug | Antibiotic Arm |
| Placebo ( FE)Participants in the Antibiotic Group will receive a standardized oral antibiotic regimen (e.g., Amoxicillin-Clavulanate) effective against the typical spectrum of low-virulence pathogens like Cutibacterium acnes. Participants in the Placebo Group will receive an identical-looking placebo. The treatment will be administered for a fixed duration of 10 days, starting immediately postoperatively. | Drug | Placebo group |
Primary outcome
re-operation within six months
Time frame: 6 months
The primary objective is to determine if this postoperative antibiotic course reduces the rate of symptomatic cSDH recurrence requiring re-operation within six months. A pre-planned subgroup analysis will be conducted to compare outcomes specifically for patients with a positive microbiological culture versus those with a negative culture.
1 secondary outcome
type of bacterial colonisation
Time frame: 2weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amoxicillin + clavulanic acid in people with Chronic Subdural Hematomas, run by University of Rostock at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel PD Dr.med.habil. Dubinski, MD MSc (+49 381 494 6439, daniel.dubinski@med.uni-rostock.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-operation within six months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.