Test and treat for regional elimination of lymphatic filariasis

Phase 3

• Conditions: ymphatic filariasis (LF); Infections and Infestations

• Registration Number: ISRCTN15320064
• Lead Sponsor: Kumasi Centre for Collaborative Research in Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-29
• Last Update Posted: 30 January 2023
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1. Age =5 years
2. LF-infected person (CFA positive)
3. Able and willing to give informed consent

Exclusion Criteria

Specific exclusion criteria for DOX 100 participants:
1. Age <14 years or >70 years
2. Body weight <40 kg
3. Pregnant or breastfeeding women
4. Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
5. Known hepatic or renal dysfunction or disease of the central nervous system (CNS)
6. History of alcohol or drug abuse
7. History of serious adverse reactions to doxycycline or other tetracyclines
8. History of photosensitivity reactions after taking drugs.
9. Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue
10. Concomitant medication with other antibiotics than doxycycline and not able to discontinue
11. Concomitant medication with diuretics, sulfonylurea or coumarin (coumadin)
12. Any significant condition other than filariasis (including medical and psychological/psychiatric disorder) which in the opinion of the study investigator might interfere with the conduct of the study

Laboratory values that will lead to exclusion:
1. Positive urine pregnancy test

Specific exclusion criteria for IDA participants:
1. Age <18 years and >70 years
2. Pregnant or breastfeeding women
3. Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
4. Known hepatic or renal dysfunction or disease of the central nervous system (CNS)
5. History of alcohol or drug abuse
6. History of serious adverse reactions to ivermectin, diethylcarbamazine or albendazole
7. Any significant condition other than filariasis (including medical and psychological/psychiatric disorder) that in the opinion of the study investigator might interfere with the conduct of the study

Laboratory values that will lead to exclusion:
1. Positive urine pregnancy test
2. Detection of Onchocerca volvulus MF in skin snips after ivermectin but prior to IDA treatment

No exclusion criteria apply to participants from the control group (MDA only)

Study & Design

• Study Type: Interventional
• Study Design: Not specified