Tropical Infectious DiseasesPALUBACNCT02669823
Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region
An observational study of Tropical Infectious Diseases, run by Sysmex Europe GmbH at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Tropical Infectious Diseases
- What is being tested?
- None, treatment as actual best practice
- How many people
- 930 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 1 Apr 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- Fever episode for more than 7 days or no informed consent was given
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Clinical Research Unit Nanaro
Nanaro, Nanaro, 218 Ouaga 11
About this study
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.
Read the 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.
- Conditions
- Tropical Infectious Diseases
- Being tested
- None, treatment as actual best practice
- Keywords
- Diagnosis
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, treatment as actual best practiceOther
| Study group | Role | What they receive |
|---|---|---|
| Children <15y | no intervention Receives: Other: None, treatment as actual best practice | |
| Adults >=15y | no intervention Receives: Other: None, treatment as actual best practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: 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
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.
Measured: 1 year based on frozen specimens
Secondary outcomes (4)
• 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
Measured: 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
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
Measured: 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.
Performance will be tested before and after training the algorithm. For description of case definitions, please see detailed description
Measured: 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.
The data will be used to train an algorithm. For description of case definitions, please see detailed description
Measured: 1 year based on frozen specimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start1 Apr 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tropical Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 930 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sysmex Europe GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Unit of Nanoro, Instituut voor Tropische Geneeskunde, Belgium, Radboud University Medical Center
- Responsible party
- Sponsor
- Investigators
- Andre van der Ven, Principal investigator, Radboud University Medical CenterHalidou Tinto, Principal investigator, CRUNJan Jacobs, Principal investigator, ITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669823
- Sponsor's protocol ID
- PALUBAC
- Acronym
- PALUBAC
- Status last verified
- Jul 2017
- First submitted
- 26 Jan 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
Publications
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.
PubMed 35418154Post 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.
PubMed 33647009Kabore 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.
PubMed 33253198Post 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.
PubMed 31146732
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region
- ClinicalTrials.gov ID
- NCT02669823
- Acronym / sponsor ID
- PALUBAC / PALUBAC
- Conditions
- Tropical Infectious Diseases
- Keywords
- Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 930 participants (actual)
- Lead sponsor
- Sysmex Europe GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Unit of Nanoro, Instituut voor Tropische Geneeskunde, Belgium, Radboud University Medical Center
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children <15y | – | Other: None, treatment as actual best practiceno intervention |
| Adults >=15y | – | Other: None, treatment as actual best practiceno intervention |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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
- AND Having one of the following clinically suspected infections
Key exclusion criteria (1 listed)
- Fever episode for more than 7 days or no informed consent was given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, treatment as actual best practice | Other | Adults >=15y, Children <15y |
Primary outcome
• 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.
• 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.
4 secondary outcomes
• Diagnostic performance of the Sysmex XN analyser to diagnose malaria compared to malaria rapid diagnostic test
Time frame: 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
• 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
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 35418154Valia 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.
- Derived from this study: PubMed 33647009Post 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.
- Derived from this study: PubMed 33253198Kabore 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.
- Derived from this study: PubMed 31146732Post 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre van der Ven principal investigator
Radboud University Medical Center
Halidou Tinto principal investigator
CRUN
Jan Jacobs principal investigator
ITG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tropical Infectious Diseases, run by Sysmex Europe GmbH at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02669823, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.