| CTRI Number |
CTRI/2020/06/025951 [Registered on: 17/06/2020] Trial Registered Prospectively |
| Last Modified On: |
16/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Development of Melioidosis Diagnostic Assay System |
|
Scientific Title of Study
|
Antigen Detection Assay for Diagnosis of Melioidosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Professor, Department of Microbiology |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Microbiology 2nd floor Basic Sciences Building
Kasturba Medical College
Udupi
KARNATAKA
576104
India |
| Phone |
09845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumi Chowdhury |
| Designation |
Junior Research Fellow |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Microbiology 2nd floor Basic Sciences Building
Kasturba Medical College
Udupi
KARNATAKA
576104
India |
| Phone |
09845513057 |
| Fax |
|
| Email |
soumi.sia1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumi Chowdhury |
| Designation |
Junior Research Fellow |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Microbiology 2nd floor Basic Sciences Building
Kasturba Medical College
Udupi
KARNATAKA
576104
India |
| Phone |
09845513057 |
| Fax |
|
| Email |
soumi.sia1995@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
InBios International Inc |
| Address |
307 Westlake Avenue N 300 Seattle WA 98109 United States |
| Type of Sponsor |
Other [Biotechnology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Soumi Chowdhury |
Kasturba Medical College |
Department of Microbiology 2nd floor Basic Sciences Building
Kasturba Medical College, Manipal Academy of Higher Education, Manipal - 576104
Udupi
KARNATAKA |
9475138726
soumi.sia1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ehics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
At least 5 years of age.
Subject able to give written informed consent/assent as appropriate. Present with at least one of the following symptoms of melioidosis:
Sepsis with unknown cause at the time of study enrollment, or Suspected cases of melioidosis by physician with a wide range of symptoms including: Type 2 diabetes with ulceration and abscesses and/or unhealed wounds; Swelling, open wounds/skin abrasions with pus; Multiple abscesses in kidneys, liver, spleen, prostate; Respiratory tract symptoms (sore throat, shortness of breath, pneumonia, cough); Fever with chills and other signs and symptoms consistent with melioidosis; Headache and other signs and symptoms consistent with melioidosis; Muscle soreness and other signs and symptoms consistent with melioidosis; Weight loss and other signs and symptoms consistent with melioidosis.
|
|
| ExclusionCriteria |
| Details |
Currently taking or have taken ceftazidime or meropenem targeting B. pseudomallei in the last 48 hours.
Previous enrollment in this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and marketised a noble diagnostic tool for one of the infectious disease like Melioidosis |
One day for each subject for AMD testing, and up to 6 days longer for collection of additional specimens for a second reference test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Active Melioidosis Detect Rapid test will help to diagnose patients with melioidosis within short period of time |
One day for each subject for AMD testing, and up to 6 days longer for collection of additional specimens for a second reference test |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will be conducted in endemic sites in which patients presenting with symptoms consistent with a diagnosis of melioidosis will be enrolled. Melioidosis symptoms include but are not limited to pneumonia, septicemia, fever, shortness of breath, chest pain, abdominal discomfort, muscle or joint pain, and skin infection with pain, swelling, or ulceration. The inclusion criteria have a full list of symptoms. After signing informed consent and if eligible for the study, subjects will have up to 4 types of samples collected for AMD testing: 1) blood for serum, 2) urine, 3) sputum and 4) fluid (pus) from skin wound, organ abscess, or infected joint. It is expected that all subjects will have serum and urine samples. Sputum or pus may be collected if available via the standard of care from each subject. The collection and preparation of the specimens for AMD testing will be performed in accordance with the Instructions for Use and the Study Procedures Manual. All of these samples will undergo AMD testing as soon as possible after collection. In addition, archival melioidosis positive specimens of each of the 4 types of samples will be introduced into the study in a blinded manner during the prospective sample collection for AMD testing to ensure the target numbers of reference test positive specimens are achieved. Samples for reference testing (bacterial culture and positive Burkholderia pseudomallei identification) will be collected at two-time points. In addition to the first time point when samples are collected for AMD testing, hospitalized subjects who have not been treated with ceftazidime or meropenem, antibiotics targeting B. pseudomallei, will also be asked to provide a second set of samples for reference testing from 3 to 6 days after the first sample collection. All specimens from both time points will be used for reference testing consisting of culture and B. pseudomallei identification. Samples for reference testing include from all subjects: 1) whole blood, 2) urine, and 3) throat swab. If available, the same pus and sputum specimens that were collected for AMD testing can be used for reference testing at the first time point. In addition, any standard of care pleural effusion and rectal swab specimens that were collected from a subject will also have reference testing performed. Reference testing includes culture and identification using clinical microbiology laboratory standard operating procedures (SOPs) appropriate for the culture and identification of B. pseudomallei. A 2 x 2 table will be constructed for
each sample type and used to calculate the PPA and NPA of the AMD Test versus
the reference tests. The number and percentages of true positives, true
negatives, false positives, and false negatives separately by sample type. PPA
and NPA will be presented by sample type along with two-sided exact (binomial –
Clopper Pearson) 95% confidence intervals (CI). Subject’s gender and disease
symptoms present on the day of testing will be presented as numbers and
percentages. Subject’s age and days post symptom onset will be presented as
summary statistics by mean, standard deviation, and range. The number of
subjects with pre-specified medical history terms will be summarized as counts
and percentages by term. Other medical history findings will be presented in a
listing. Body temperature will be presented as summary statistics. |