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Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region (PALUBAC)

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ClinicalTrials.gov Identifier: NCT02669823
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
Clinical Research Unit of Nanaro (CRUN), Burkina Faso
Instituut voor Tropische Geneeskunde (ITG), Belgium
Radboud University
Information provided by (Responsible Party):
Sysmex Europe GmbH

Brief Summary:
Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate clinically. This poses a particular threat in low resource areas, where bBSI is often not diagnosed due to the unavailability of rapid diagnostic means. Even if used appropriately, the sensitivity of blood culture to diagnose bBSI is estimated to be around 50%. To counter the high mortality rate associated with bBSI, antibiotics are often prescribed without microbiological confirmation. Sysmex Company has developed technology that enables the rapid diagnosis of malaria using a venous blood sample. In addition algorithms based on hematological parameters can be used to monitor disease severity and progression, as well as guide further diagnostic testing based on differences seen in these parameters between various types of disease. The algorithms have been developed and tested in adult populations from different industrialized countries and in one Asian population. However no data are available neither from pediatric patients, nor from the sub-Saharan setting where the epidemiology of infectious diseases is very different from the tested settings. The objective of the study is to: 1) Assess the sensitivity and specificity of the Sysmex hematology analyzer based on the new technology to diagnose malaria in subjects older than 3 months, who present with an acute severe febrile illness in a malaria endemic area in sub-Saharan Africa 2) Test and optimize the value of Sysmex analyzers in disease diagnosis and monitoring in children older than 5 years and adults, who present with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa, to differentiate between severe malaria and bBSI, or a combination of these infections. 3) Explore the value of Sysmex analyzers in disease diagnosis and monitoring in children between 3 months and 5 years of age, who present with an acute severe febrile illness in a malaria endemic region in sub-Saharan Africa.

Condition or disease Intervention/treatment
Tropical Infectious Diseases Other: None, treatment as actual best practice

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 930 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Children <15y
no intervention
Other: None, treatment as actual best practice
Adults >=15y
no intervention
Other: None, treatment as actual best practice



Primary Outcome Measures :
  1. • 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.


  2. • 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.



Secondary Outcome Measures :
  1. • 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

  2. • 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


  3. • 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

  4. • 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



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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting at the district health center with suspicion of infectious disease. Since the amendment which passed in November 2016 this includes outpatients as well as inpatients.
Criteria

Inclusion Criteria:

  1. Children between ages >3 months and < 15 years old OR adults of 15 years and above
  2. 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.
  3. 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)
  4. 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669823


Locations
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Burkina Faso
Clinical Research Unit Nanaro
Nanaro, Burkina Faso, 218 Ouaga 11
Sponsors and Collaborators
Sysmex Europe GmbH
Clinical Research Unit of Nanaro (CRUN), Burkina Faso
Instituut voor Tropische Geneeskunde (ITG), Belgium
Radboud University
Investigators
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Principal Investigator: Andre van der Ven Radboud University
Principal Investigator: Halidou Tinto CRUN
Principal Investigator: Jan Jacobs ITG

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sysmex Europe GmbH
ClinicalTrials.gov Identifier: NCT02669823     History of Changes
Other Study ID Numbers: PALUBAC
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Sysmex Europe GmbH:
Diagnosis

Additional relevant MeSH terms:
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Malaria
Bacterial Infections
Communicable Diseases
Infection
Protozoan Infections
Parasitic Diseases