UMIN-CTR Clinical Trial

Public title

Sensitivity and Specificity of Gram's stain for the detection of Campylobacter spp. in stool

Acronym

Utility of stool Gram's stain for the dection of Campylobacter spp.

Scientific Title

Sensitivity and Specificity of Gram's stain for the detection of Campylobacter spp. in stool

Scientific Title:Acronym

Utility of stool Gram's stain for the dection of Campylobacter spp.

Region

Japan

Condition

Gastrointestinal infection/Campylobacter spp.

Classification by specialty

Medicine in general

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the clinical utility of stool Gram's stain for the detection of Campylobacter spp.

Basic objectives2

Others

Basic objectives -Others

Other purposes of this study are as follows; i) to investigate the clinical utility of an antigen testing for the detection of Capmylobacter spp. in stool and ii) to examine the accuracy of disease probabilities estimated by caring physicians, regarding Campylobacter gastroenteritis.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of the sensitivity and specificity of stool Gram's stain for the detection of Campylobacter spp.

Key secondary outcomes

1) To investigate variance between examiners, regarding the diagnostic accuray of Gram's stain for the detection of Campylobacter spp.
2) To assess whether the diagnostic accuracy of Gram's stain improves over time, regarding the detection of Campylobacter spp.
3) To compare the sensitivity and specificity of an antigen testing (Quicknavi-Campylo) with those of stool Gram's stain, regarding the detection of Campylobacter spp.
4) To measure the turn around time of the antigen testing (Quicknavi-Campylo) and to investigate its clinical utility for the the detection of Campylobacter spp.
5) To compare between the physician-estimated disease probabilities (pretest probabilities) of Campylobacter gastroenteritis and the positive rate of stool cultures/nucleic acid amplification test

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Residual samples used for stool cultre
We prospectively measure the turnaround time of antigen testing and investigate the physician-estimated disease probabilities for Campylobacter gastroenteritis, only when patients provide written consent for participation in this study.

Key exclusion criteria

None

Target sample size

300

Name of lead principal investigator

1st name	Yusaku
Middle name
Last name	Akashi

Organization

Tsukuba Medical Center Hospital

Division name

Division of Infectious Diseases, Department of Medicine

Zip code

305-8558

Address

1-3-1, Amakubo, Tsukuba, Ibaraki

TEL

029-851-3511

Email

yusaku-akashi@umin.ac.jp

Name of contact person

1st name	Hiroichi
Middle name
Last name	Ishikawa

Organization

Tsukuba Medical Center Hospital

Division name

Department of Respiratory Medicine

Zip code

305-8558

Address

1-3-1, Amakubo, Tsukuba, Ibaraki

TEL

029-851-3511

Homepage URL

Email

hishikawa@tmch.or.jp

Institute

Tsukuba Medical Center Hospital

Institute

Department

Personal name

Organization

Tsukuba Medical Center Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Tsukuba Medical Center Hospital

Address

1-3-1, Amakubo, Tsukuba, Ibaraki

Tel

029-851-3511

Email

hishikawa@tmch.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

10

Month

20

Day

URL releasing protocol

https://onlinelibrary.wiley.com/doi/full/10.1002/jgf2.596

Publication of results

Published

URL related to results and publications

https://onlinelibrary.wiley.com/doi/full/10.1002/jgf2.596

Number of participants that the trial has enrolled

205

Results

For the microscopic examination, the sensitivity and specificity were 53.5% and 98.1% for physician A, 46.7% and 96.2% for physician B, 63.0% and 100% for the clinical laboratory technician, and 67.4% and 100% for microbiologists, respectively. The antigen testing was evaluated in 131 of the 205 samples and showed a sensitivity of 93.3% and specificity of 99.0%. Microscopic examination of the stool samples showed high specificity.

Results date posted

2023

Year

10

Month

23

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Patient demographic data is summarised as follows. The median age was 23.0 years (interquartile range [IQR]: 8.0-40.0) and 94 (45.9%) of patients were female. Comorbidities were present in 23 (11.2%) patients, including seven (3.4%) patients with cerebrovascular disease, six (2.9%) with diabetes mellitus, and four (2.0%) with dementia. Prior to the sample collection, antibiotics had been prescribed for 27 (13.2%) patients.

Participant flow

The study included outpatients and inpatients (within 72 hours of admission) with suspected infectious gastroenteritis. Exclusion criteria were (i) patients who did not have infectious gastroenteritis, (ii) in whom residual specimens were not available, (iii) patients who refused to participate in the study, and (iv) duplicate cases. Both direct microscopy and antigen testing used fresh stool samples within 24 hours of collection. For microscopic examination, smeared samples were Gram stained using Bartholomew and Mittwer modified reagents (Muto Pure Chemicals Co. Ltd). Smeared sampleswere anonymised by study number, stored in a storage box and then examined at 1000x magnification. Microscopic examinations were performed by two physicians (physician A [board-certified in family and geriatric medicine] and physician B [board-certified in emergency medicine]), a clinical laboratory technician, and microbiologists. We independently checked and recorded the presence or absence of spiral-shaped gram-negative bacilli. Clinical information was not reviewed during microscopic examination. Antigen testing was performed according to the manufacturer's instructions. Briefly, samples were dispensed into the extraction solution and added to the wells of the kit. Similar to other lateral flow antigen tests, the test was considered positive for Campylobacter spp. if a positive test line appeared.

Adverse events

No adverse events occured in the study.

Outcome measures

We collected the patients' clinical information retrospectively from their medical records, and recorded the results of both microscopic examinations and antigen tests. The clinical information collected included age, sex, comorbidities, symptoms (fever, chills, diarrhoea, haemorrhoids, vomiting, abdominal pain, and myalgia/arthralgia), and previous antibiotic use.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2017

Year

05

Month

01

Day

Date of IRB

2017

Year

05

Month

01

Day

Anticipated trial start date

2017

Year

05

Month

01

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Collected variables

*Patients' demographic data: age, sex, occupation, clinical signs and symptoms, general condition of patients, duration of symptoms, close contact with gastroenteritis patients, travel history, prescription of antimicrobial agent, requirement of hospital admission, requirement of parenteral fluid therapy
*Laboratory results: WBC count, AST, ALT, LDH, CK, blood glucose, rapid tests for infectious diseases
*Results of image studies
*Appearance of stool sample and Bristol stool scale
*Results of stool culture/nucleic acid amplification test
*Results and turnaround time of the antigen testing
*Clinical assessment of disease probabilities for Campylobacter gastroenteritis

Registered date

2019

Year

10

Month

20

Day

Last modified on

2023

Year

10

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041847