Study selection criteria | Definition |
---|---|
Clinical inclusion criteria | Age ≥ 14 years and ≤ 65 years |
Male or non-pregnant woman of childbearing-potential using an approved, effective method of contraception before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo | |
Able to give informed consent/assent to participate in the trial | |
Resident in an LF endemic area for five years (> 2 years for TAKeOFF) | |
Body weight ≥ 40 kg | |
Lymphoedema of at least one limb Stage 1-6 measured on a 7-point scale. (Stage 2 or 3 for podoconiosis) | |
Ability to use established standardized methods of hygiene and effectively applying it prior to initiation of drug treatment | |
No evidence of severe or systemic co-morbidities (except for features of filarial disease) | |
Normal laboratory profile (type of investigations and normal limits in the case of haematological abnormalities are site-specific) | |
Consent to storage of blood samples for further study (site specific) | |
Negative pregnancy test | |
Clinical exclusion criteria | No lymphoedema or lymphoedema stage 7 |
Age < 14 years or > 65 years | |
Body weight < 40 kg | |
Pregnant or breastfeeding women | |
Women of childbearing potential not using an agreed method of contraception | |
Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease | |
Alcohol or drug abuse | |
History of adverse reactions to doxycycline or other tetracyclines | |
Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator | |
History of photosensitivity reactions after taking drugs | |
Concomitant medication with antacids containing aluminium, magnesium or sucralfate and not able to discontinue | |
Concomitant medication with other antibiotics than doxycycline and not able to discontinue | |
Concomitant medication with diuretics or sulfonylurea or coumarin | |
Laboratory exclusion criteria | Haemoglobin < 8 g/dl |
Neutrophil count < 1100/mm3 | |
Platelet count < 100,000/mm3 | |
Creatinine > 2 times upper limit of normal | |
AST (GOT), ALT (GPT), gamma-GT > 2 times upper limit of normal | |
Positive urine pregnancy test |