Infectious Pseudochromdrosis Caused by Bacillus Cereus | NCT05507086

Studies
Infectious Pseudochromdrosis Caused by Bacillus Cereus

NCT05507086

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Aug 23, 2022Actual

Enrollment

12Estimated

Phase

Not provided

Conditions

Infectious Disease
Bacterial Overgrowth
Pigment Deposition

Interventions

Antimicrobial therapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Aug 17, 2022

First Submission Date that Met QC Criteria

Aug 17, 2022

First Posted Date

Aug 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2022

Last Update Posted Date

Aug 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christoffer Aam Ingvaldsen, Researcher, University Hospital, AkershusPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Estimated

Name	Type	Description	Arm Group Labels	Other Names
Antimicrobial therapy	Other	Antimicrobial therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Remission	Descriptive / physical examination	1 year
Repeated bacteriological swab	Repeated bacteriological swab if uncertainty in terms of complete remission	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infectious pseudochromhidrosis caused by Bacillus cereus

Exclusion Criteria:

Other types of blue chromhidrosis

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Twelve patients with blue sweat (infectious pseudochromhidrosis) caused by Bacillus cereus

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoffer A Ingvaldsen, MD PhD	Contact	004741271030		aamingvaldsen@gmail.com
Truls M Leegaard, MD PhD	Contact			truls.michael.leegaard@ahus.no

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Microbiology	Recruiting	Lørenskog	Akershus	1478	Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003141	Communicable Diseases

Ancestor Terms

ID	Term
D007239	Infections
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided