Doxycycline to improve filarial lymphedema (LEDoxy Tanzania)

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 420

Inclusion Criteria

1. Lymphedema of at least one leg grade 1-6 measured on a 7-point scale [3]
2. Age = 14 years and = 65 years
3. Men or non-pregnant women. If women of childbearing-potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo
4. Negative pregnancy test
5. Body weight = 40 kg
6. Resident in LF endemic area for = 2 years
7. Able and willing to give informed consent/ to provide assent to participate in the trial
8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment

Exclusion Criteria

1. No lymphedema or lymphedema stage 7
2. Age < 14 years or > 65 years
3. Body weight < 40 kg
4. Pregnant or breastfeeding women
5. Women of childbearing potential not using an agreed method of contraception (including abstinence; oral contraceptives are not allowed because of interaction with trial drugs)
6. Clinical or biologic evidence of hepatic or renal dysfunction or disease of the central nervous system (CNS)
7. Evidence of severe comorbidities except for features of filarial disease
8. Alcohol or drug abuse
9. History of adverse reactions to doxycycline or other tetracyclines
10. Any significant condition (including medical and psychological/ psychiatric disorder) which in the opinion of the study investigator might interfere with the conduct of the study
11. History of photosensitivity reactions after taking drugs.
12. Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue
13. Concomitant medication with other antibiotics than doxycycline and not able to discontinue
14. Concomitant medication with diuretics or sulfonylurea
15. Concomitant medication with coumarin
16. Haemoglobin < 8 gm/dL
17. Neutrophil count <2000/mm3 - updated 03/08/2018: Neutrophil count <1100/mm3
18. Platelet count <100,000/mm3
19. Creatinine > 2 times upper limit of normal
20. AST (GOT) > 2 times upper limit of normal
21. ALT (GPT) > 2 times upper limit of normal
22. Gamma-GT > 2 times upper limit of normal
23. Positive urine pregnancy test

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ack of progression of lymphedema (LE) (stage reduction or same stage as pre-treatment using the 7-point scale staging according to Dreyer et al, 2002), examined 24 months after treatment onset

Secondary Outcome Measures

Name	Time	Method

Related Trials

Doxycycline to improve filarial lymphedema (LEDoxy Ghana)

CompletedPhase 2

Kumasi Centre for Collaborative Research (KCCR)

Updated 1/30/2023