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CTRI Number  CTRI/2021/11/038015 [Registered on: 12/11/2021] Trial Registered Prospectively
Last Modified On: 03/05/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Clinical Performance Evaluation 
Study Design  Other 
Public Title of Study   Specimen Collection for the Development and Validation of the Xpert® Tropical Fever Test  
Scientific Title of Study   A Study to Generate Clinical Performance of Cepheid XAFIP-101 Test Cartridges on the GeneXpert® Instrument Systems for Detection of P.malariae, P.falciparum, Dengue virus, Zika Virus, Chikungunya Virus, Leptospira Species, and Salmonella Species in Whole Blood Specimens. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
258-S   Protocol Number 
Version- v6.0 28Oct21  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Kapil Arora 
Designation  Vice President 
Affiliation  Apothecaries Clinical Research LLP 
Address  Plot No. 129 G/8, N.S.E.Z, Noida Dadri Road, Noida 201305

Gautam Buddha Nagar
UTTAR PRADESH
201305
India 
Phone  9868898699  
Fax    
Email  reachus@apothecaries.net  
 
Details of Contact Person
Scientific Query  
Name  Kapil Arora 
Designation  Vice President 
Affiliation  Apothecaries Clinical Research LLP 
Address  876, Udyog Vihar Phase V, Gurgaon- 122 016

Gurgaon
HARYANA
122 016
India 
Phone  9868898699  
Fax    
Email  kapil.arora@apothecaries.net  
 
Details of Contact Person
Public Query  
Name  Kapil Arora 
Designation  Vice President 
Affiliation  Apothecaries Clinical Research LLP 
Address  876, Udyog Vihar Phase V, Gurgaon- 122 016

Gurgaon
HARYANA
122 016
India 
Phone  9868898699  
Fax    
Email  kapil.arora@apothecaries.net  
 
Source of Monetary or Material Support  
Cepheid 904 Caribbean Drive Sunnyvale, CA 94089  
 
Primary Sponsor  
Name  Cepheid 
Address  904, Caribbean Drive, Sunnyvale,CA94089,USA 
Type of Sponsor  Other [Molecular Diagnostics Company] 
 
Details of Secondary Sponsor  
Name  Address 
Apothecaries Clinical Research LLP  Plot No. 129 G/8, N.S.E.Z, Noida Dadri Road, Noida 201305  
 
Countries of Recruitment     Cambodia
India
Kenya
Peru
Tanzania
United States of America  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K Sankar  Aarupadai Veedu Medical College and Hospital  Kirumampakkam, Pondicherry, 605014
Pondicherry
PONDICHERRY 		 9003482085

sankar.kalairajan@avmc.edu.in 
Dr Sunita Kapoor  City X-Ray & Scan Clinic Pvt. Ltd.  5A/34, Tilak Nagar, New Delhi-110018
New Delhi
DELHI 		 08800999400

drkapoor.city@gmail.com 
Dr Sunil Singhvi  Sri Singhvi Health Centre  127, Bricklin road, Pursaiwakkam, Chennai, Tamilnadu
Chennai
TAMIL NADU 		 9841113147

drsunilsinghvi@gmail.com 
Dr Vanitha Gnanasoundran Sundarasamy  Vinayaka Missions Medical College  Keezhakasakudi, Karaikal, Pondicherry- 609609
Karaikal
PONDICHERRY 		 9443550001

ctb@vmmckkl.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Independent Ethics Committee, Society for Research & Welfare  Approved 
Institutional Ethics Committee, , Vinayaka Missions Medical College  Approved 
Institutional Human Ethics Committee Aarupadai Veedu Medical College and Hospital   Approved 
Universal Ethics Committee, A unit of Aurous Healthcare R & D India Pvt. Ltd.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere, (2) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (3) ICD-10 Condition: B509||Plasmodium falciparum malaria, unspecified, (4) ICD-10 Condition: B519||Plasmodium vivax malaria without complication, (5) ICD-10 Condition: B529||Plasmodium malariae malaria without complication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  i.Age ≥12 years, and,
ii.Acute febrile illness with oral,tympanic,or rectal temperature ≥38°C(≥100.4°F)or axillary or frontal temperature ≥37.5°C (≥99.5°F); for 10 days or less, and,
iii.Signs & symptoms arising clinical suspicion of one of the fever-causing pathogens being studied (Malaria, Dengue,Zika,Chikungunya, Leptospira and/or Salmonella), and,
iv.History of residence in or travel, within the last 3 months, to geographic region(s)in which the transmission of above diseases occurs, and,
v.Willing and able to provide the required amount of finger-stick and venous blood without compromising own well-being,(as evidenced by written informed consent). 
 
ExclusionCriteria 
Details  i.Enrolment in this protocol within the last 5 days, or,
ii.Acute febrile illness that has been ongoing for >10 days, or,
iii.Self-reported or known use within the past 3 days,of any antibiotic or antimalarial medication for the treatment of Leptospira or Salmonella infections, or Malaria, or
iv.Bodyweight <11 kg, or,
v.Any other conditions, including severe illness, which, in the opinion of the investigator, will make the patient unsuitable for the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i)Information on recovery and any sequelae; results of specific tests or treatment that may have been conducted
ii)For a fatal outcome, cause of death and a note on its possible relationship to the
suspected event; any post-mortem findings
iii)Other information: anything relevant to facilitate the assessment of the case, such as
medical history including allergy, drug or alcohol abuse; family history; findings from
special investigations, etc. 		 The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the prevalence of Malaria,Dengue,Zika, Chikungunya,Leptospirosis,and Salmonellosis in subjects presenting with acute febrile illness in geographic areas where the sites are located.  The primary endpoint of this study is to determine the point estimates and 95% confidence intervals for the positive percent agreement (PPA) and negative percent agreement (NPA)for the Cepheid XAFIP-101 Test Cartridge on GeneXpert® Instrument Systems, relative to comparator methods 
 
Target Sample Size   Total Sample Size="3500"
Sample Size from India="2500" 
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)   15/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/11/2020 
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)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This clinical study only pertains to acquisition of anonymized blood specimens from patients.
This protocol does not involve any investigational treatment. Results from Investigational Diagnostic Equipment and Cartridges Would Not be Shared with the Patients and Will Not Affect Their Treatment.
The procedures involved in this clinical study are considered to involve minor increase over minimal risk or low risk (ICMR) and noninvasive (US).
According to ICMR’s National Ethical Guidelines for Biomedical and Health Research involving Human Participants 2017, minor increase over minimal risk or low risk is defined as increment in probability of harm or discomfort is only a little more than the minimal risk threshold. According to US CFR 21 Part 812.3(k), blood sampling that involves simple venipuncture is considered noninvasive.
Primary Study Objective:
To establish the analytical and clinical performance of the Cepheid XAFIP-101 Test Cartridges on GeneXpert® Omni Systems for the qualitative detection of Plasmodium species (includes P. vivax, P. malariae, P. ovale, P. knowlesi not differentiated, and P. falciparum special call-out), Dengue virus (Serotypes DENV-1 to 264 DENV-4 not differentiated), Zika virus, Chikungunya virus, Leptospira species, and Salmonella species in whole blood specimens collected by finger-stick and venous blood drawn from subjects who are symptomatic for fever without localizing signs.

Secondary Study Objectives:
i) To establish the analytical and clinical performance of the Cepheid XAFIP-101 Test Cartridges on the GeneXpert® DX System (a real-time PCR instrument currently available on-market for commercial purchase) for the qualitative detection of Plasmodium species (includes P. vivax, P. malariae, P. ovale, P. knowlesi not differentiated, and P. falciparum special call-out), Dengue virus (Serotypes DENV-1 to DENV-4 not differentiated), Zika virus, Chikungunya virus, Leptospira species, and Salmonella species in whole blood specimens collected by finger-stick and venous blood drawn from subjects who are symptomatic for fever without localizing signs.
ii) To determine the prevalence of Malaria, Dengue, Zika, Chikungunya, Leptospirosis, and Salmonellosis in subjects presenting with acute febrile illness in geographic areas where the sites are located.
 
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