Tropical Infectious Diseases Clinical Trial
— PALUBACOfficial title:
Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region
| Verified date | July 2017 |
| Source | Sysmex Europe GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 930 |
| Est. completion date | June 30, 2017 |
| Est. primary completion date | June 30, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Months and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Burkina Faso | Clinical Research Unit Nanaro | Nanaro |
| Lead Sponsor | Collaborator |
|---|---|
| Sysmex Europe GmbH | Clinical Research Unit of Nanaro (CRUN), Burkina Faso, Instituut voor Tropische Geneeskunde (ITG), Belgium, Radboudumc, Algemeen Interne Geneeskunde, The Netherlands |
Burkina Faso,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | • Diagnostic sensitivity and specificity of Sysmex XN blue laser for malaria parasite detection in a malaria endemic area | 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 | |
| Primary | • 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 | 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 | • Diagnostic performance of the Sysmex XN analyser to diagnose malaria compared to malaria rapid diagnostic test | 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 | |
| Secondary | • Diagnostic sensitivity and specificity of Sysmex XN analyser to diagnose viral infections or non-bacteremic bacterial infections with or without malaria | 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 | |
| Secondary | • 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. | 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 | |
| Secondary | • To develop and optimize an algorithm to diagnose viral and bacterial infection in children below 5 years of age. | The data will be used to train an algorithm. For description of case definitions, please see detailed description | 1 year based on frozen specimens |