Human African TrypanosomiasisPhase 4NECT-FIELDNCT00906880
Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase
A Phase 4 study testing Nifurtimox-Eflronithine Combination Treatment (NECT) in people with Human African Trypanosomiasis, run by Drugs for Neglected Diseases at 6 sites in Republic of the Congo.
Trial summary
Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human African Trypanosomiasis
- What is being tested?
- Nifurtimox-Eflronithine Combination Treatment (NECT)
- Type of treatment
- Injection or infusion
- How many people
- 630 participants
- Where
- 6 sitesRepublic of the Congo
- Study dates
- Apr 2009to Jan 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients diagnosed as stage 2 HAT according to the diagnostic protocols in use at the treatment center (generally, if presence of parasites in blood, lymph node fluid or CSF and an elevated white blood cell count in the CSF, but this can vary from center to center) will be included if a written Informed Consent is given by the patient or a legally acceptable representative if the patient is a minor or unable to communicate.
- Pregnancy and breastfeeding women: On a case by case basis according to the guidelines of the National HAT Control Programme or the NGO, the Investigator will decide to treat the patient or to defer the treatment. In case of inclusion, the mother-child pairs or the children of lactating mothers will be closely monitored during treatment and follow up.
- Children under 2 years of age: On a case by case basis, the Investigator will decide to treat an infant with NECT or an alternative treatment (preferably eflornithine). In case of inclusion, these infants will be closely monitored during treatment and follow up like all children less than 12 years of age.
Who cannot join
- Unable to take oral medication, and impossibility to use a nasogastric tube.
- Treatment failure after nifurtimox-eflornithine treatment.
- Any other condition or reason for which the Investigator (or the responsible treating staff member) judges that another or no HAT treatment is warranted.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Republic of the Congo6 sites
HGR (General Reference Hospital) Bandundu
Bandundu, Bandundu
CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda
Katanda, East Kasai
HGR (General Reference Hospital) Kwamouth
Kwamouth, Bandundu
CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital
Mbuji Mayi, East Kasai
HGR (General Reference Hospital) Ngandajika
Ngandajika, East Kasai
HGR (General Reference Hospital) Yasa Bonga
Yasa Bonga, Bandundu
About this study
Official title: Clinical Study to Assess the Clinical Tolerability, Feasibility and Effectiveness Under Field Conditions of the Combination of Nifurtimox and Eflornithine (NECT) for the Treatment of T.b.Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Stage
Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase.
Overall objectives:
Read more
Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the National HAT Control Programme, NGO treatment centers).
Primary objective:
- Assess the clinical response of the NECT co-administration under field conditions.
Secondary objectives:
- Assess the incidence and type of adverse events (AE), and the capacity of the treatment centers to deal with these.
- Assess the feasibility of the implementation of the NECT coadministration by the health center.
- Assess the effectiveness of the NECT co-administration at 24* months after treatment.
- Conditions
- Human African Trypanosomiasis
- Being tested
- Nifurtimox-Eflronithine Combination Treatment (NECT)
- Keywords
- Human African Trypanosomiasis, HAT, sleeping sickness, combination treatment, nifurtimox, eflornithine, Human African Trypanosomiasis in the meningo-encephalitic phase (stage 2 HAT)
- Medical subject headings
- Trypanosomiasis, African
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifurtimox-Eflronithine Combination Treatment (NECT)Drug
Also called nifurtimox (Lampit), eflornithine (Ornidyl)
co-administration of nifurtimox (10 days, 15 mg/kg/day, p.o. TID) and eflornithine (7 days, 400 mg/kg/day, i.v. BID)
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients discharged alive from the hospital or the treatment center
Secondary outcomes (3)
Incidence of serious AE (SAE) and severe AE (CTC score 3 and 4) related to treatment, and overall frequency and nature of AE and need for additional medications to manage these.
Measured: up to 24 months after treatment
Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of HAT)
Measured: 24 months after treatment
Number of temporary treatment interruptions, number of premature treatment cessations, length of hospitalization stay (including observation period), treatment compliance (deviation in dosing), and other feasibility indicators.
Measured: during the treatment/hospitalisation time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2010
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Human African TrypanosomiasisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Swiss Tropical & Public Health Institute
- Responsible party
- Sponsor
- Investigators
- Johannes Blum, MD, Principal investigator, Swiss Tropical & Public Health InstituteVictor Kande, MD, Principal investigator, PNLTHA-DRC;
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906880
- Sponsor's protocol ID
- HAT0208
- Acronym
- NECT-FIELD
- Status last verified
- May 2013
- First submitted
- 19 May 2009
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schmid C, Kuemmerle A, Blum J, Ghabri S, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Tete D, Mubwa N, Kisala M, Blesson S, Mordt OV. In-hospital safety in field conditions of nifurtimox eflornithine combination therapy (NECT) for T. b. gambiense sleeping sickness. PLoS Negl Trop Dis. 2012;6(11):e1920. doi: 10.1371/journal.pntd.0001920. Epub 2012 Nov 29.
PubMed 23209861Kuemmerle A, Schmid C, Bernhard S, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Tete DN, Kisala M, Burri C, Blesson S, Valverde Mordt O. Effectiveness of Nifurtimox Eflornithine Combination Therapy (NECT) in T. b. gambiense second stage sleeping sickness patients in the Democratic Republic of Congo: Report from a field study. PLoS Negl Trop Dis. 2021 Nov 8;15(11):e0009903. doi: 10.1371/journal.pntd.0009903. eCollection 2021 Nov.
PubMed 34748572Kuemmerle A, Schmid C, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Ngolo D, Kisala M, Valverde Mordt O. Prescription of concomitant medications in patients treated with Nifurtimox Eflornithine Combination Therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo. PLoS Negl Trop Dis. 2020 Jan 27;14(1):e0008028. doi: 10.1371/journal.pntd.0008028. eCollection 2020 Jan.
PubMed 31986140
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Assess the Clinical Tolerability, Feasibility and Effectiveness Under Field Conditions of the Combination of Nifurtimox and Eflornithine (NECT) for the Treatment of T.b.Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Stage
- ClinicalTrials.gov ID
- NCT00906880
- Acronym / sponsor ID
- NECT-FIELD / HAT0208
- Conditions
- Human African Trypanosomiasis
- Keywords
- Human African Trypanosomiasis, HAT, sleeping sickness, combination treatment, nifurtimox, eflornithine, Human African Trypanosomiasis in the meningo-encephalitic phase (stage 2 HAT)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Ministry of Public Health, Democratic Republic of the Congo, Swiss Tropical & Public Health Institute
- Study start
- Apr 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 May 2009 (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.
Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase.
Overall objectives:
Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the National HAT Control Programme, NGO treatment centers).
Primary objective:
- Assess the clinical response of the NECT co-administration under field conditions.
Secondary objectives:
- Assess the incidence and type of adverse events (AE), and the capacity of the treatment centers to deal with these.
- Assess the feasibility of the implementation of the NECT coadministration by the health center.
- Assess the effectiveness of the NECT co-administration at 24* months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All patients diagnosed as stage 2 HAT according to the diagnostic protocols in use at the treatment center (generally, if presence of parasites in blood, lymph node fluid or CSF and an elevated white blood cell count in the CSF, but this can vary from center to center) will be included if a written Informed Consent is given by the patient or a legally acceptable representative if the patient is a minor or unable to communicate.
- Pregnancy and breastfeeding women: On a case by case basis according to the guidelines of the National HAT Control Programme or the NGO, the Investigator will decide to treat the patient or to defer the treatment. In case of inclusion, the mother-child pairs or the children of lactating mothers will be closely monitored during treatment and follow up.
- Children under 2 years of age: On a case by case basis, the Investigator will decide to treat an infant with NECT or an alternative treatment (preferably eflornithine). In case of inclusion, these infants will be closely monitored during treatment and follow up like all children less than 12 years of age.
Key exclusion criteria (3 listed)
- Unable to take oral medication, and impossibility to use a nasogastric tube.
- Treatment failure after nifurtimox-eflornithine treatment.
- Any other condition or reason for which the Investigator (or the responsible treating staff member) judges that another or no HAT treatment is warranted.
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 |
|---|---|---|
| Nifurtimox-Eflronithine Combination Treatment (NECT)Also: nifurtimox (Lampit), eflornithine (Ornidyl)co-administration of nifurtimox (10 days, 15 mg/kg/day, p.o. TID) and eflornithine (7 days, 400 mg/kg/day, i.v. BID) | Drug | – |
Primary outcome
Proportion of patients discharged alive from the hospital or the treatment center
3 secondary outcomes
Incidence of serious AE (SAE) and severe AE (CTC score 3 and 4) related to treatment, and overall frequency and nature of AE and need for additional medications to manage these.
Time frame: up to 24 months after treatment
Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of HAT)
Time frame: 24 months after treatment
Number of temporary treatment interruptions, number of premature treatment cessations, length of hospitalization stay (including observation period), treatment compliance (deviation in dosing), and other feasibility indicators.
Time frame: during the treatment/hospitalisation time
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 31 May 2013.
- Results publication: PubMed 23209861Schmid C, Kuemmerle A, Blum J, Ghabri S, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Tete D, Mubwa N, Kisala M, Blesson S, Mordt OV. In-hospital safety in field conditions of nifurtimox eflornithine combination therapy (NECT) for T. b. gambiense sleeping sickness. PLoS Negl Trop Dis. 2012;6(11):e1920. doi: 10.1371/journal.pntd.0001920. Epub 2012 Nov 29.
- Derived from this study: PubMed 34748572Kuemmerle A, Schmid C, Bernhard S, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Tete DN, Kisala M, Burri C, Blesson S, Valverde Mordt O. Effectiveness of Nifurtimox Eflornithine Combination Therapy (NECT) in T. b. gambiense second stage sleeping sickness patients in the Democratic Republic of Congo: Report from a field study. PLoS Negl Trop Dis. 2021 Nov 8;15(11):e0009903. doi: 10.1371/journal.pntd.0009903. eCollection 2021 Nov.
- Derived from this study: PubMed 31986140Kuemmerle A, Schmid C, Kande V, Mutombo W, Ilunga M, Lumpungu I, Mutanda S, Nganzobo P, Ngolo D, Kisala M, Valverde Mordt O. Prescription of concomitant medications in patients treated with Nifurtimox Eflornithine Combination Therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo. PLoS Negl Trop Dis. 2020 Jan 27;14(1):e0008028. doi: 10.1371/journal.pntd.0008028. eCollection 2020 Jan.
- Sponsor websiteLink provided by the sponsor.
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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.
Johannes Blum, MD principal investigator
Swiss Tropical & Public Health Institute
Victor Kande, MD principal investigator
PNLTHA-DRC;
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifurtimox-Eflronithine Combination Treatment (NECT) in people with Human African Trypanosomiasis, run by Drugs for Neglected Diseases at 6 sites in Republic of the Congo.
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 3 inclusion and 3 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Republic of the Congo. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients discharged alive from the hospital or the treatment center. 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 NCT00906880, which also lists 3 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 31 May 2013.