- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02669823
Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region (PALUBAC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Analytical plan
Sysmex will be blinded to:
- All clinical data except age and gender of the participant
- All laboratory and imaging data that is not obtained by the XN-analyzers.
The clinical study team will be blinded to:
- Data from the XN-analyzers, excepting the currently validated data that is used for routine patient care (e.g. total blood count, white blood differentiation)
Two researchers from Sysmex and two researchers from the study team will use the data available to them (i.e. the data to which they are not blinded) to categorize each patient according to the following categories (independently from each other) using the predefined case definitions as mentioned above.
- Confirmed malaria parasitemia
- Confirmed bacterial infection
- Confirmed viral infection
- Suspected malaria
- Suspected bacterial infection
- Suspected viral infection
- Mixed infection (specified which combination)
- No infection
Analysis for primary outcome measures
- Diagnostic sensitivity and specificity of blue laser compared to microscopy/PCR
- ROC curve to assess best cut-off for the blue laser based on clinical samples
- Linear regression analysis to compare quantification of parasitemia by blue laser to microscopy/PCR
- Compare performance of the blue laser to performance of RDT (in comparison to microscopy/PCR)
- Diagnostic sensitivity and specificity of infection manager to detect bBSI in participants of 5 years and older.
- Diagnostic sensitivity and specificity of the infection manager to detect bBSI combined with malaria in participants of 5 years and older.
Case definitions:
Malaria parasitemia is defined as the presence of one or more parasites in malaria microscopy or a malaria qPCR 18S result over 50 p/ml
Bacterial bloodstream infection is defined as growth of a clinically significant bacterial organism from blood culture within 5 days of incubation or a (16s) PCR result positive for a clinically significant organism
Lower respiratory tract infection: a clinical suspicion including cough and/or shortness of breath, supported by results from chest exam and chest X-ray.
Abscess: in case of superficial abscesses clinical presentation must be confirmed by pus upon drainage. In case of deep abscesses the clinical presentation must be confirmed by echography.
Meningitis: A clinical suspicion with decreased conscience and neck stiffness, confirmed by culture or agglutination performed on cerebrospinal fluid.
Pelvic inflammatory infection: Typical clinical presentation with vaginal discharge
Protrude skin infections: clinical presentation combined with a grown pathogen in skin culture or presence of pus.
Bacterial gastro-enteritis: Patients with diarrhoea and a grown pathogen from stool culture.
Urinary tract infections: Patients clinical signs of a urinary tract infection and a grown pathogen from urine culture.
Obvious causes of fever include superficial skin infection, superficial abscesses, otitis, pharyngitis and tonsillitis.
Viral infections will be diagnosed based on clinical suspicion and confirmed using PCR or serology.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Nanaro, Burkina Faso, 218 Ouaga 11
- Clinical Research Unit Nanaro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children between ages >3 months and < 15 years old OR adults of 15 years and above
- AND willing and able to provide written informed consent (parent's or guardian's consent for minors). In case of very sick adults not able to give consent, sampling will be done and ICF will be asked upon his/her recovery or from his/her representative in case of death.
AND presenting with one of the following:
Recorded temperature of > 38.0°C or temperature < 35.5°C (tympanic). OR episode of fever within 48 hours prior to admission
OR signs of severe clinical illness including one or more of the following:
- Respiratory distress
- Prostration
- Altered consciousness
- Convulsions (one or more episodes)
- Clinical jaundice
- Signs of shock
- Severe malnutrition with severe anemia (hemoglobin < 5 g/dl)
AND Having one of the following clinically suspected infections
- Severe malaria
- Invasive bacterial infection (including pneumonia, arthritis, peritonitis, meningitis or complicated urinary tract infection, typhoid fever)
- Severe viral infection such as influenza
Exclusion Criteria:
• Fever episode for more than 7 days or no informed consent was given
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children <15y
no intervention
|
|
Adults >=15y
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• Diagnostic sensitivity and specificity of Sysmex XN blue laser for malaria parasite detection in a malaria endemic area
Time Frame: 1 year based on frozen specimens
|
based on microscopy of a blood smear or PCR in case of a negative smear or incongruent results. Diagnostic performance will be evaluated before and after training of the algorithm. Malaria parasitemia is defined as the presence of one or more parasites in malaria microscopy or a malaria qPCR 18S result over 50 p/ml. |
1 year based on frozen specimens
|
• Diagnostic sensitivity and specificity of Sysmex XN infection manager for diagnosing bacterial bloodstream infection (bBSI) and mixed malaria/bBSI in a malaria endemic area in participants of 5 years and older
Time Frame: 1 year based on frozen specimens
|
Diagnostic performance will be evaluated before and after training of the algorithm. Malaria parasitemia is defined as the presence of one or more parasites in malaria microscopy or a malaria qPCR 18S result over 50 p/ml Bacterial bloodstream infection is defined as growth of a clinically significant bacterial organism from blood culture within 5 days of incubation or a (16s) PCR result positive for a clinically significant organism. |
1 year based on frozen specimens
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
• Diagnostic performance of the Sysmex XN analyser to diagnose malaria compared to malaria rapid diagnostic test
Time Frame: 1 year based on frozen specimens
|
Malaria parasitemia is defined as the presence of one or more parasites in malaria microscopy or a malaria qPCR 18S result over 50 p/ml
|
1 year based on frozen specimens
|
• Diagnostic sensitivity and specificity of Sysmex XN analyser to diagnose viral infections or non-bacteremic bacterial infections with or without malaria
Time Frame: 1 year based on frozen specimens
|
In participants of 5 years and older. Performance will be tested before and after training the algorithm. For description of case definitions, please see detailed description |
1 year based on frozen specimens
|
• Comparison of diagnostic performance of Sysmex XN analyser compared with C-reactive protein and procalcitonin in diagnosing malaria with or without co-infections, bacterial and viral infections.
Time Frame: 1 year based on frozen specimens
|
Performance will be tested before and after training the algorithm.
For description of case definitions, please see detailed description
|
1 year based on frozen specimens
|
• To develop and optimize an algorithm to diagnose viral and bacterial infection in children below 5 years of age.
Time Frame: 1 year based on frozen specimens
|
The data will be used to train an algorithm.
For description of case definitions, please see detailed description
|
1 year based on frozen specimens
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andre van der Ven, Radboud university medical center
- Principal Investigator: Halidou Tinto, CRUN
- Principal Investigator: Jan Jacobs, ITG
Publications and helpful links
General Publications
- Post A, Kabore B, Reuling IJ, Bognini J, van der Heijden W, Diallo S, Lompo P, Kam B, Herssens N, Lanke K, Bousema T, Sauerwein RW, Tinto H, Jacobs J, de Mast Q, van der Ven AJ. The XN-30 hematology analyzer for rapid sensitive detection of malaria: a diagnostic accuracy study. BMC Med. 2019 May 31;17(1):103. doi: 10.1186/s12916-019-1334-5.
- Valia D, Ingelbeen B, Kabore B, Karama I, Peeters M, Lompo P, Vlieghe E, Post A, Cox J, de Mast Q, Robert A, van der Sande MAB, Villalobos HR, van der Ven A, Tinto H, Jacobs J. Use of WATCH antibiotics prior to presentation to the hospital in rural Burkina Faso. Antimicrob Resist Infect Control. 2022 Apr 13;11(1):59. doi: 10.1186/s13756-022-01098-8.
- Post A, Kabore B, Bognini J, Diallo S, Lompo P, Kam B, Herssens N, van Opzeeland F, van der Gaast-de Jongh CE, Langereis JD, de Jonge MI, Rahamat-Langendoen J, Bousema T, Wertheim H, Sauerwein RW, Tinto H, Jacobs J, de Mast Q, van der Ven AJ. Infection Manager System (IMS) as a new hemocytometry-based bacteremia detection tool: A diagnostic accuracy study in a malaria-endemic area of Burkina Faso. PLoS Negl Trop Dis. 2021 Mar 1;15(3):e0009187. doi: 10.1371/journal.pntd.0009187. eCollection 2021 Mar.
- Kabore B, Post A, Berendsen MLT, Diallo S, Lompo P, Derra K, Rouamba E, Jacobs J, Tinto H, de Mast Q, van der Ven AJ. Red blood cell homeostasis in children and adults with and without asymptomatic malaria infection in Burkina Faso. PLoS One. 2020 Nov 30;15(11):e0242507. doi: 10.1371/journal.pone.0242507. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PALUBAC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tropical Infectious Diseases
-
Centre de Recherche Médicale de LambarénéNot yet recruitingTropical Infectious Disease
-
Institut PasteurCompleted
-
University of VirginiaUniversity of VendaActive, not recruitingEnvironmental Exposure | Diarrhoea;Infectious;Presumed | Diarrhea, Infantile | Diarrhea Tropical | Enteropathy | Malnutrition, ChildSouth Africa
-
BioRed LLCUnknown
-
Washington University School of MedicineBaylor College of Medicine; Kamuzu University of Health Sciences; United States...Completed
-
University of VermontWashington University School of Medicine; Bill and Melinda Gates Foundation; Stanford... and other collaboratorsCompletedVaccine Virus Shedding | Tropical Enteropathy | Rotavirus DiarrheaBangladesh
-
Universidad Nacional de SaltaCIVETAN CONICET, Facultad de Ciencias Veterinarias, UNCPBA. TandilCompletedNeglected Tropical Diseases | Soil Transmitted Helminthiasis
-
St. Marianna University School of MedicineUnknownHTLV-I-Associated MyelopathyJapan
-
Washington University School of MedicineNational Public Health Institute of LiberiaNot yet recruitingOnchocerciasis | Onchocerciasis, Ocular | Tropical Disease | Onchocercal Subcutaneous Nodule | Onchocerca InfectionLiberia
-
International Vaccine InstituteBill and Melinda Gates Foundation; University of Vermont; University of Virginia and other collaboratorsCompletedPoliomyelitis | Tropical EnteropathyIndia
Clinical Trials on None, treatment as actual best practice
-
Sunnybrook Health Sciences CentreWomen's College Hospital; Sunnybrook Research InstituteRecruiting
-
Judge Baker Children's CenterUniversity of Illinois at Chicago; University of Hawaii; MacArthur FoundationCompleted
-
Nova Scotia Health AuthorityCompletedMajor Depressive DisorderCanada
-
AB Biotics, SACompletedDepressive Disorder, MajorSpain
-
Singapore General HospitalDSO National Laboratories; Health Sciences Authority, SingaporeCompletedHypoproliferative ThrombocytopeniaSingapore
-
Cadila PharnmaceuticalsCouncil of Scientific and Industrial Research, IndiaCompleted
-
Queen's UniversityThe Ottawa Hospital; University of OttawaCompleted
-
Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Duke University; Montefiore Medical... and other collaboratorsCompletedMajor Depressive DisorderUnited States
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Rutgers UniversityRecruiting
-
University of South FloridaUniversity of California, Los Angeles; Temple UniversityCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety Disorder | Specific Phobia | Autism | Autism Spectrum Disorders | Obsessive-compulsive Disorder | Asperger's Syndrome | Pervasive Developmental Disability - Not Otherwise SpecifiedUnited States