Trypanosomiasis, AfricanPhase 2/3NECSNCT00489658
Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda
A Phase 2/3 study testing Eflornithine plus Nifurtimox combination therapy in people with Trypanosomiasis, African, run by Epicentre at 1 site in Uganda.
Trial summary
This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trypanosomiasis, African
- What is being tested?
- Eflornithine plus Nifurtimox combination therapy
- How many people
- 31 participants
- Where
- 1 siteUganda
- Study dates
- Oct 2002to not given
- Phase
- Phase 2/3
- 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
- Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF > 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count
- Residence in the study area
- Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)
Who cannot join
- Pregnancy or clinical history suggestive thereof
- Weight < 10 Kg
- History of any HAT treatment within the previous 24 months
- Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge
- Severe anemia (Hb< 5g/dl)
- Active tuberculosis (sputum positive)
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- HIV positive (if patient has been tested and results are known)
- Severe renal or hepatic failure
- Bacterial or cryptococcal meningitis
- Other severe underlying diseases upon admission
- Refugee status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda
This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.
- Conditions
- Trypanosomiasis, African
- Being tested
- Eflornithine plus Nifurtimox combination therapy
- Keywords
- Human African trypanosomiasis, sleeping sickness, Trypanosoma brucei gambiense, combination, eflornithine, nifurtimox, Human African trypanosomiasis (sleeping sickness) due to Trypanosoma brucei gambiense in the late stage (stage 2 or meningo-encephalitic)
- Medical subject headings
- Trypanosomiasis, African
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eflornithine plus Nifurtimox combination therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge)
Measured: 24 months
Secondary outcomes (2)
Occurrence and severity of serious clinically apparent adverse events
Measured: treatment period and up to one month post discharge
Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events
Measured: treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startOct 2002
Why it stopped: Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trypanosomiasis, AfricanStudies 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 2/3
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Médecins Sans Frontières, France
- Investigators
- Patrice Piola, MD MSc, Principal investigator, EpicentreGerardo Priotto, MD MPH, Study director, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489658
- Sponsor's protocol ID
- NECS
- Acronym
- NECS
- Status last verified
- Jun 2007
- First submitted
- 20 Jun 2007
- Last updated
- 21 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Priotto G, Fogg C, Balasegaram M, Erphas O, Louga A, Checchi F, Ghabri S, Piola P. Three drug combinations for late-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Uganda. PLoS Clin Trials. 2006 Dec 8;1(8):e39. doi: 10.1371/journal.pctr.0010039.
PubMed 17160135
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of an Eflornithine + Nifurtimox Combination for Treatment of Late-Stage Human African Trypanosomiasis (HAT) in West Nile, Uganda
- ClinicalTrials.gov ID
- NCT00489658
- Acronym / sponsor ID
- NECS / NECS
- Conditions
- Trypanosomiasis, African
- Keywords
- Human African trypanosomiasis, sleeping sickness, Trypanosoma brucei gambiense, combination, eflornithine, nifurtimox, Human African trypanosomiasis (sleeping sickness) due to Trypanosoma brucei gambiense in the late stage (stage 2 or meningo-encephalitic)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Médecins Sans Frontières, France
- Study start
- Oct 2002
- First posted
- 21 Jun 2007 (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.
This case series study follows on a terminated randomised clinical trial in a nearby location of Uganda, in which the combination of eflornithine + nifurtimox showed very promising efficacy and safety. The study's purpose is to evaluate the efficacy and safety of this combination in a larger group of late-stage Human African trypanosomiasis (sleeping sickness) patients.
Study design
- 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)
- Stage 2 infection with Trypanosoma brucei gambiense diagnosed within the previous 14 days, as defined by either of the following: (i) Presence of trypanosomes in blood or lymph node fluid and WBC count in CSF > 5 / mm3, or (ii) Presence of trypanosomes in the CSF with any CSF WBC count
- Residence in the study area
- Written informed consent (to be obtained from parent/guardian for children under 18 years and patients with impaired cognition)
Key exclusion criteria (11 listed)
- Pregnancy or clinical history suggestive thereof
- Weight < 10 Kg
- History of any HAT treatment within the previous 24 months
- Inability to undergo hospitalisation or attend follow-up visits during the 24 months following discharge
- Severe anemia (Hb< 5g/dl)
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 |
|---|---|---|
| Eflornithine plus Nifurtimox combination therapy | Drug | – |
Primary outcome
Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge)
Time frame: 24 months
2 secondary outcomes
Occurrence and severity of serious clinically apparent adverse events
Time frame: treatment period and up to one month post discharge
Occurrence and severity of biochemical (ALAT, creatinine, bilirubin) and haematological (abnormal total and differential leukocyte count, haemoglobin) adverse events
Time frame: treatment period
Results and safety
The study was stopped early (reason given: Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2007.
- Background: PubMed 17160135Priotto G, Fogg C, Balasegaram M, Erphas O, Louga A, Checchi F, Ghabri S, Piola P. Three drug combinations for late-stage Trypanosoma brucei gambiense sleeping sickness: a randomized clinical trial in Uganda. PLoS Clin Trials. 2006 Dec 8;1(8):e39. doi: 10.1371/journal.pctr.0010039.
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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.
Patrice Piola, MD MSc principal investigator
Epicentre
Gerardo Priotto, MD MPH study director
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eflornithine plus Nifurtimox combination therapy in people with Trypanosomiasis, African, run by Epicentre at 1 site in Uganda.
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 11 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: stopped early, as of the sponsor's last update on 21 Jun 2007. 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 Uganda. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Because of unexpectedly reduced disease prevalence in the study area, a pragmatic decision was taken to terminate recruitment in March 2003.). Results are not available in the source record.
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?
Treatment failure (death within 30 days of inclusion, or later if judged as related to Human African trypanosomiasis; termination of treatment due to adverse events; evidence of infection relapse at or after discharge, up to 24 months post discharge) (time frame: 24 months). 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 NCT00489658, which also lists 1 linked publication.
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 Jun 2007.