Infectious DiseaseBlue sweatNCT05507086
Infectious Pseudochromdrosis Caused by Bacillus Cereus
An observational study of Infectious Disease and Bacterial Overgrowth, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Disease, Bacterial Overgrowth, Pigment Deposition
- What is being tested?
- Antimicrobial therapy
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus
Who may be able to join
- Infectious pseudochromhidrosis caused by Bacillus cereus
Who cannot join
- Other types of blue chromhidrosis
Trial locations and contacts
1 site in 1 country.
Truls M Leegaard, MD PhD contact
Norway1 site, 1 recruiting
- Recruiting
Department of Microbiology
Lørenskog, Akershus, 1478
Christoffer Ingvaldsen, MD PhD, 004741271030, aamingvaldsen@gmail.com
Truls M Leegaard, MD PhD, truls.michael.leegaard@ahus.no
About this study
Official title: Blue Sweat - Infectious Pseudochromdrosis Caused by Bacillus Cereus
Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus.
Read the detailed description
Case series/observational study. Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus. Demography, clinical presentation, diagnosis, treatments, microbiology and causality.
- Conditions
- Infectious Disease, Bacterial Overgrowth, Pigment Deposition
- Being tested
- Antimicrobial therapy
- Keywords
- Infectious pseudochromhidrosis, Chromhidrosis, Sweat, Bacillus cereus
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial therapyOther
Antimicrobial therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
Descriptive / physical examination
Measured: 1 year
Repeated bacteriological swab
Repeated bacteriological swab if uncertainty in terms of complete remission
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoffer Aam Ingvaldsen, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507086
- Sponsor's protocol ID
- IPCH2
- Acronym
- Blue sweat
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blue Sweat - Infectious Pseudochromdrosis Caused by Bacillus Cereus
- ClinicalTrials.gov ID
- NCT05507086
- Acronym / sponsor ID
- Blue sweat / IPCH2
- Conditions
- Infectious Disease, Bacterial Overgrowth, Pigment Deposition
- Keywords
- Infectious pseudochromhidrosis, Chromhidrosis, Sweat, Bacillus cereus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Aug 2022 (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.
Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus.
Detailed description
Case series/observational study. Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus. Demography, clinical presentation, diagnosis, treatments, microbiology and causality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus
Key inclusion criteria (1 listed)
- Infectious pseudochromhidrosis caused by Bacillus cereus
Key exclusion criteria (1 listed)
- Other types of blue chromhidrosis
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 |
|---|---|---|
| Antimicrobial therapyAntimicrobial therapy | Other | – |
Primary outcome
Remission
Time frame: 1 year
Descriptive / physical examination
Repeated bacteriological swab
Time frame: 1 year
Repeated bacteriological swab if uncertainty in terms of complete remission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- 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. This study is not recruiting at the moment.
Truls M Leegaard, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease and Bacterial Overgrowth, run by Oslo University Hospital at 1 site in Norway.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Aug 2022. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoffer A Ingvaldsen, MD PhD (004741271030, aamingvaldsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: 1 year). The study lists 2 primary outcomes in all. 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 23 Aug 2022.