MalariaHIPPINCT06769815
Host Immunity, Plasmodium and Pathogens Co-Infections
A study testing Blood sample, Urine sample and oropharyngeal sample in people with Malaria and Bacterial Co-infection, run by Institut Pasteur.
Trial summary
Few studies have focused on malaria co-infections, mainly caused by Plasmodium falciparum, occurring mainly in children under 5 years of age in sub-Saharan Africa. These studies have focused on malaria-associated bacterial sepsis, with an estimated prevalence of 9.1% and associated mortality of 15.0%. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria, Bacterial Co-infection
- What is being tested?
- Blood sample, Urine sample and oropharyngeal sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Febrile children:
- aged between 6 and 60 months
- with a febrile episode lasting less than 7 days (axillary temperature >=37.5° Celsius)
- whose state of health is compatible with a minimum single blood sample volume of 6.25 ml
- Non-febrile children:
- aged between 6 and 60 months
Show all 17Show fewer
- with axillary temperature <37.5° Celsius
- no clinical signs of infection at the time of inclusion
- no infectious episode or fever for 7 days
- Pregnant women :
- giving birth in the project's partner health center
- intending to reside in the study area during the newborn follow-up period
- with a mono-fetal pregnancy
- With an apparently uncomplicated delivery not requiring referral to a higher-level health facility
- Newborns at delivery:
- Born at term (determined by Ballard score)
- whose parents or legal guardians reside in the study area during the newborn's follow-up period
Who cannot join
- For all :
- person already participating in another biomedical research project.
- For febrile and non-febrile children:
- chronic non-infectious pathology (cancer, malnutrition, etc.)
- For pregnant women
- scheduled caesarean section for current pregnancy
- Caesarean section in previous pregnancies
- chronic non-infectious pathology during pregnancy (diabetes, hypertension, pre-eclampsia)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Few studies have focused on malaria co-infections, mainly caused by Plasmodium falciparum, occurring mainly in children under 5 years of age in sub-Saharan Africa. These studies have focused on malaria-associated bacterial sepsis, with an estimated prevalence of 9.1% and associated mortality of 15.0%. However, no study has documented infectious sites other than the blood compartment, considered viruses and parasites as possible causes of infection in addition to bacteria, and used molecular diagnostic methods based on PCRs, which are more sensitive. Thus, the prevalence of these co-infections and the spectrum of pathogens involved are probably underestimated, as is the impact of these co-infections on mortality. Furthermore, it has been shown that malaria infections can condition the immune cells of naturally exposed individuals, potentially leading to greater susceptibility to all types of infection. But these mechanisms have never been documented in the context of co-infections.
The WHO recommends the use of broad-spectrum antibiotics in cases of severe malaria, in addition to antimalarial drugs, as it can be difficult to differentiate clinically between severe malaria and severe bacterial infection (bacteremia, pneumonia and meningitis). Yet this empirical use of antibiotics could be contributing to an increase in antibiotic resistance. Identifying the determinants of co-infection with malaria and severe bacterial infection would enable this treatment to be better targeted.
These determinants remain undetermined as no study has considered other causes of severe bacterial infection other than bacteremia, used appropriate statistical methodology (univariate analysis only) and explored important determinants, notably the capacity of children's innate immunity to respond to severe bacterial infection.
Read the detailed description
This is a prospective multicenter longitudinal study.
The study will focus on several populations:
- febrile children: aged between 6 and 60 months consulting ;
- non-febrile children: aged between 6 and 60 months consulting.
- Pregnant women.
- newborns: those born to mothers included in the study with or without pregnancy-associated malaria.
The study will be based on :
- Clinical and microbiological documentation of acute febrile episodes in recruited children
- Documentation of vital status in children 3 months after recruitment
- Ability of host cells to respond to infections.
- Conditions
- Malaria, Bacterial Co-infection
- Being tested
- Blood sample, Urine sample, oropharyngeal sample, Optionnal : stool sample, Optionnal : cerebrospinal fluid
- Keywords
- malaria, co-infection, immune response, epigenetic mechanisms, children, Togo
- Medical subject headings
- Malaria, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
For febrile children at the time of inclusion : 6.25 ml to 8.25 ml of blood ; For non febrile children at the time of inclusion : 4 ml of blood ; For pregnant women at the time of inclusion : 5 ml of peripheral blood, 5 ml of placental blood, 20 to 40 ml of umbilical cord blood ; For new borns : drop of blood on child's heel each month and 5 ml of blood the 12th and last month.
Urine sampleOther
For febrile children : 10 ml of urine
oropharyngeal sampleOther
For febrile children : oropharyngeal swab sampling
Optionnal : stool sampleOther
For febrile children (only as part of the care of the child) : 5g stool
Optionnal : cerebrospinal fluidOther
For febrile children (only as part of the care of the child in case of suspected meningitis) : 4 additional drops of cerebrospinal fluid
placental biopsyOther
For pregnant women : placental biopsy the size of 2 rice grains
| Study group | Role | What they receive |
|---|---|---|
| Febrile and non febrile children, pregnant women and new borns | Other | The study population is composed of children under the age of 5, which is also the population most at risk of malaria, living in the endemic areas of Lomé and Tsévié in Togo. Receives: Other: Blood sample; Other: Urine sample; Other: oropharyngeal sample; Other: Optionnal : stool sample; Other: Optionnal : cerebrospinal fluid; Other: placental biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the extent and microbiological spectrum of malaria co-infections in children under 5.
the number of malaria co-infection events in febrile children.
Measured: 3 years
Secondary outcomes (5)
Assess the impact of malaria co-infections on mortality
Number of deaths in children under 5 with malaria co-infection
Measured: 2 years
Identify the underlying immunological mechanisms mediating malaria co-infections
Concentration of cytokines IL6, IL1β and TNFα and IL 10 in children under 5 years of age
Measured: 2 years
Identify epigenetic and transcriptomic modifications in infant, maternal and placental blood cells mediating malaria co-infections
Expression level of transcripts according to the populations studied will be measured by RNA-seq
Measured: 2 years
Identify molecules associated with epigenetic modifications (metabolome, proteome).
Expression level of proteins and metabolites according to the populations studied will be measured by RNA-seq
Measured: 2 years
Identify determinants of malaria co-infections and severe bacterial infections.
The number of malaria co-infection events associated with severe bacterial infection in febrile children under 5 years of age.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherche pour le Developpement
- Responsible party
- Sponsor
- Investigators
- Bich-Tram Huynh, PhD, Study director, Institut PasteurLuc Douti, MD, Principal investigator, CHU-Campus de LoméSerge Ekoué Gbadoe, MD, Principal investigator, Hôpital de district Polyclinique de Zio-Tsévié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769815
- Sponsor's protocol ID
- 2023-079
- Other IDs
- IRB2024-01, 043/2024/CBRS
- Acronym
- HIPPI
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Host Immunity, Plasmodium and Pathogens Co-Infections
- ClinicalTrials.gov ID
- NCT06769815
- Acronym / sponsor ID
- HIPPI / 2023-079
- Conditions
- Malaria, Bacterial Co-infection
- Keywords
- malaria, co-infection, immune response, epigenetic mechanisms, children, Togo
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut de Recherche pour le Developpement
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- 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.
Few studies have focused on malaria co-infections, mainly caused by Plasmodium falciparum, occurring mainly in children under 5 years of age in sub-Saharan Africa. These studies have focused on malaria-associated bacterial sepsis, with an estimated prevalence of 9.1% and associated mortality of 15.0%. However, no study has documented infectious sites other than the blood compartment, considered viruses and parasites as possible causes of infection in addition to bacteria, and used molecular diagnostic methods based on PCRs, which are more sensitive. Thus, the prevalence of these co-infections and the spectrum of pathogens involved are probably underestimated, as is the impact of these co-infections on mortality. Furthermore, it has been shown that malaria infections can condition the immune cells of naturally exposed individuals, potentially leading to greater susceptibility to all types of infection. But these mechanisms have never been documented in the context of co-infections.
The WHO recommends the use of broad-spectrum antibiotics in cases of severe malaria, in addition to antimalarial drugs, as it can be difficult to differentiate clinically between severe malaria and severe bacterial infection (bacteremia, pneumonia and meningitis). Yet this empirical use of antibiotics could be contributing to an increase in antibiotic resistance. Identifying the determinants of co-infection with malaria and severe bacterial infection would enable this treatment to be better targeted.
These determinants remain undetermined as no study has considered other causes of severe bacterial infection other than bacteremia, used appropriate statistical methodology (univariate analysis only) and explored important determinants, notably the capacity of children's innate immunity to respond to severe bacterial infection.
Detailed description
This is a prospective multicenter longitudinal study.
The study will focus on several populations:
- febrile children: aged between 6 and 60 months consulting ;
- non-febrile children: aged between 6 and 60 months consulting.
- Pregnant women.
- newborns: those born to mothers included in the study with or without pregnancy-associated malaria.
The study will be based on :
- Clinical and microbiological documentation of acute febrile episodes in recruited children
- Documentation of vital status in children 3 months after recruitment
- Ability of host cells to respond to infections.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Febrile and non febrile children, pregnant women and new borns | Other | Other: Blood sample, Other: Urine sample, Other: oropharyngeal sample, Other: Optionnal : stool sample, Other: Optionnal : cerebrospinal fluid, Other: placental biopsyThe study population is composed of children under the age of 5, which is also the population most at risk of malaria, living in the endemic areas of Lomé and Tsévié in Togo. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- aged between 6 and 60 months
- with a febrile episode lasting less than 7 days (axillary temperature >=37.5° Celsius)
- whose state of health is compatible with a minimum single blood sample volume of 6.25 ml
- aged between 6 and 60 months
- with axillary temperature <37.5° Celsius
Key exclusion criteria (8 listed)
- person already participating in another biomedical research project.
- chronic non-infectious pathology (cancer, malnutrition, etc.)
- For pregnant women
- scheduled caesarean section for current pregnancy
- Caesarean section in previous pregnancies
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 |
|---|---|---|
| Blood sampleFor febrile children at the time of inclusion : 6.25 ml to 8.25 ml of blood ; For non febrile children at the time of inclusion : 4 ml of blood ; For pregnant women at the time of inclusion : 5 ml of peripheral blood, 5 ml of placental blood, 20 to 40 ml of umbilical cord blood ; For new borns : drop of blood on child's heel each month and 5 ml of blood the 12th and last month. | Other | Febrile and non febrile children, pregnant women and new borns |
| Urine sampleFor febrile children : 10 ml of urine | Other | Febrile and non febrile children, pregnant women and new borns |
| oropharyngeal sampleFor febrile children : oropharyngeal swab sampling | Other | Febrile and non febrile children, pregnant women and new borns |
| Optionnal : stool sampleFor febrile children (only as part of the care of the child) : 5g stool | Other | Febrile and non febrile children, pregnant women and new borns |
| Optionnal : cerebrospinal fluidFor febrile children (only as part of the care of the child in case of suspected meningitis) : 4 additional drops of cerebrospinal fluid | Other | Febrile and non febrile children, pregnant women and new borns |
| placental biopsyFor pregnant women : placental biopsy the size of 2 rice grains | Other | Febrile and non febrile children, pregnant women and new borns |
Primary outcome
Determine the extent and microbiological spectrum of malaria co-infections in children under 5.
Time frame: 3 years
the number of malaria co-infection events in febrile children.
5 secondary outcomes
Assess the impact of malaria co-infections on mortality
Time frame: 2 years
Identify the underlying immunological mechanisms mediating malaria co-infections
Time frame: 2 years
Identify epigenetic and transcriptomic modifications in infant, maternal and placental blood cells mediating malaria co-infections
Time frame: 2 years
Identify molecules associated with epigenetic modifications (metabolome, proteome).
Time frame: 2 years
Identify determinants of malaria co-infections and severe bacterial infections.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
Bich-Tram Huynh, PhD study director
Institut Pasteur
Luc Douti, MD principal investigator
CHU-Campus de Lomé
Serge Ekoué Gbadoe, MD principal investigator
Hôpital de district Polyclinique de Zio-Tsévié
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Urine sample and oropharyngeal sample in people with Malaria and Bacterial Co-infection, run by Institut Pasteur.
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 17 inclusion and 8 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: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bich-Tram Huynh, PhD (+33 1 53 55 18 50, bich-tram.huynh@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the extent and microbiological spectrum of malaria co-infections in children under 5. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.