NCT00803933

Brief Summary

Human African Trypanosomiasis or sleeping sickness has made a spectacular return during the last decade, and in many places the demand largely surpasses the capacities of the treatment centers. Treatment of the disease remains unsatisfactory. All currently used drugs must be administered parenterally, treatment is lengthy, and adverse drug reactions frequent. There are currently no drugs that are easily administered and have low toxicity, and might thus be used as tools to support disease control. This study aims to compare the safety and efficacy of DB289, a new, orally administered dication prodrug to pentamidine i.m. injection for the treatment of first stage sleeping sickness. The project will be executed in the framework of an international consortium consisting of several partners from academia, industry and from the Democratic Republic of Congo Ministries of Health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2003

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2008

Completed
Last Updated

December 8, 2008

Status Verified

December 1, 2008

Enrollment Period

1 year

First QC Date

December 4, 2008

Last Update Submit

December 5, 2008

Conditions

African Trypanosomiasis

Keywords

first stageTrypanosoma brucei gambienseT. b. gambiensesleeping sicknessFirst stage T. b. gambiense sleeping sickness

Outcome Measures

Primary Outcomes (2)

  • The primary efficacy endpoint was the parasitological cure at 3 months after completion of treatment.

    3 months

  • The primary outcome measure for safety analysis was the rate of occurrence of Grade 3 or higher adverse events during the observation period.

    12 day

Secondary Outcomes (2)

  • The secondary outcome measure was the incidence rate of adverse events (all Grades combined) during the 7- to 9-day observation period in Treatment Sequence 1 and during the 12-day observation period in Treatment Sequence 2.

    12 day

  • The number and percentage of subjects with parasitological cure, subjects with confirmed (parasitological) treatment failure, and subjects with suspected treatment failure at 6, 12, and 24 months after completion of treatment.

    6, 12, 24 months

Study Arms (2)

DB289

EXPERIMENTAL

Pafuramidine maleate (DB289), 100 mg BID orally

Drug: DB289

Pentamidine

ACTIVE COMPARATOR

Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Drug: Pentamidine

Interventions

DB289DRUG

Pafuramidine maleate (DB289), 100 mg BID orally

Also known as: pafuramidine maleate
DB289
PentamidineDRUG

Pentamidine isethionate (Aventis) for injection (200 mg/vial), 4 mg/kg QD IM

Pentamidine

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The patient has early stage T. b. gambiense infection i.e. parasitologically confirmed infection in the blood or lymph node aspirate and greater than or equal to 5 WBC mm-3 detected in the CSF by microscopic examination
  • Patient is 15 to 50 years old
  • Patient has a minimal weight of 35 kilograms
  • If the patient is female of child bearing potential (a women will be considered of non-child bearing potential only if she has been post menopausal for over 2 years or has had a hysterectomy):
  • she is not lactating,
  • she had a negative urine pregnancy test result within 24 hours prior to DB289 treatment and
  • she agrees to use a medically proven method of contraception (abstinence from sexual intercourse is an acceptable method) from the day of consent on until the end of the observation period (day 7).
  • Patient has understood and signed the Informed Consent. If the patient is minor, a legal guardian has signed the Informed Consent

You may not qualify if:

  • The patient has late stage T.b. gambiense infection i.e. presence of parasite in the CSF upon microscopic examination or a WBC count of \> 5mm-1
  • Active clinically relevant medical conditions that in the Investigator opinion may jeopardize subject safety or interfere with participation in the study, including but not limited to: significant liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, infection including known HIV infection, CNS trauma or seizure disorders (A list of typical signs and symptoms is provided for guidance of the investigator in attachment 1)
  • Coma Score of less than 9 on the Glasgow Coma Scale (Appendix 8)
  • Withdrawal of consent at any time during the study
  • Any condition which compromises ability to communicate with the investigator as required for the completion of this study.
  • The subject has been previously treated for African Trypanosomiasis.
  • The subject has been previously enrolled in the study. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CDTC Maluku

Gombé, Kinshasa, Republic of the Congo

Location

Vanga Hospital

Gombé, Kinshasa, Republic of the Congo

Location

Related Publications (1)

  • Burri C, Yeramian PD, Allen JL, Merolle A, Serge KK, Mpanya A, Lutumba P, Mesu VK, Bilenge CM, Lubaki JP, Mpoto AM, Thompson M, Munungu BF, Manuel F, Josenando T, Bernhard SC, Olson CA, Blum J, Tidwell RR, Pohlig G. Efficacy, Safety, and Dose of Pafuramidine, a New Oral Drug for Treatment of First Stage Sleeping Sickness, in a Phase 2a Clinical Study and Phase 2b Randomized Clinical Studies. PLoS Negl Trop Dis. 2016 Feb 16;10(2):e0004362. doi: 10.1371/journal.pntd.0004362. eCollection 2016 Feb.

    PMID: 26881924DERIVED

MeSH Terms

Conditions

Trypanosomiasis, African

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Intervention Hierarchy (Ancestors)

BenzamidinesAmidinesOrganic Chemicals

Study Officials

  • Victor Kande, MD

    Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 8, 2008

Study Start

February 1, 2003

Primary Completion

February 1, 2004

Study Completion

June 1, 2005

Last Updated

December 8, 2008

Record last verified: 2008-12

Locations

RE(2)