NCT00127504

Brief Summary

The purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

July 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2005

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

First QC Date

August 4, 2005

Last Update Submit

August 13, 2024

Conditions

Onchocerciasis

Keywords

OnchocerciasisWolbachiaTherapy

Outcome Measures

Primary Outcomes (1)

  • Eliminating Wolbachia endobacteria present in O. volvulus worms after 9 months

Secondary Outcomes (1)

  • Elimination of microfilaria in skin snips and histological examination of worms after 9 months

Interventions

RifampinDRUG
AzithromycinDRUG

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males and non-pregnant/non lactating females \>5 years of age
  • One onchocercal nodule in an anatomical position where it can be easily removed surgically

You may not qualify if:

  • Pregnancy (based on urine pregnancy test)
  • Breast-feeding
  • Women taking oral contraceptives
  • Allergy or other adverse reaction to either medication
  • Use of other medications that might interact with rifampin
  • Clinical evidence of liver disease (jaundice, swollen abdomen)
  • Clinical evidence of chronic disease/alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad del Valle/MERTU

Guatemala City, Guatemala

Location

MeSH Terms

Conditions

Onchocerciasis

Interventions

RifampinAzithromycin

Condition Hierarchy (Ancestors)

FilariasisSpirurida InfectionsSecernentea InfectionsNematode InfectionsHelminthiasisParasitic DiseasesInfectionsSkin Diseases, ParasiticSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Josef Amann, MD, MPH

    CDC/NCID/DPD

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 4, 2005

First Posted

August 8, 2005

Study Start

July 1, 2003

Study Completion

May 1, 2004

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

GU(1)