Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere Health Condition 2: B978- Other viral agents as the cause ofdiseases classified elsewhere Health Condition 3: B509- Plasmodium falciparum malaria, unspecified Health Condition 4: B529- Plasmodium malariae malaria without complication Health Condition 5: B519- Plasmodium vivax malaria without complication
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Cepheid
Apothecaries Clinical Research LLP
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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 v.Any other conditions, including severe illness, which, in the opinion of the investigator, will make the patient unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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 | — |
Countries
Cambodia, India, Kenya, Peru, Tanzania, United States of America
Contacts
Public ContactKapil Arora
Apothecaries Clinical Research LLP
Outcome results
None listed